clinical research project management

Clinical Project Manager

Clinical trial management certification.

Demo Clinical Project Manager Training

Research Project Manager Certification

CCRPS Research Manager Graduates obtained job roles including:

Clinical Trial Project Manager, Research Nurse Manager, Clinical Research Coordinator-Data Manager, Clinical Research Associate, Transdisciplinary Research Project Manager, IT Project Manager in Clinical Research, Publicly Funded Research Project Manager (2024 CCRPS Graduate LinkedIn Survey).

Clinical Research Project Manager Training

Advanced Clinical Research Associate Certification (ACRAC)

Introduction

CME Handout

Common Terminology Used In Clinical Research - Reference Glossary

Commonly Used Abbreviations and Terms in Clinical Research

An Overview of ICH GCP

CFR 21 Part 11

Ethics of Research Involving Children

Ethics of Research Involving Mentally Incapacitated

Ethics of Research Involving Pregnant Women and Fetuses

Fundamentals of Project Management

Project Management Fundamentals

PMBOK Summary - Mandatory Project Management Review

Clinical Trial Project Management

Importance of Project Management

Roles and Relationships in Clinical Trials

Role of a Project Sponsor

ICH GCP E6 Section 5 - Sponsor/CRO Responsibilities

Institutional Review Board/Ethics Committee (IRB/EC) (Requirements, sIRB, Application, Exemptions, Expedited Review, Continuation, and Reporting)

Data Safety Monitoring board- DSMB

Stakeholders in Clinical Trials (Sponsor, Project Manager, IRB, PI, CRA, CRC, Site Staff, Data Team/DSMB, Patients)

Contract Research Organizations (Delegation, Responsibilities, Management )

ICH GCP E6 Sections 2-4 Principles, IRB, & Investigator Roles

ICH GCP E6 Section 4 - Reporting Responsibilities of the Investigators

Skills of a Project Manager

Essential skills of a Project Manager

Technical skills for Project Management

Project Team

Managing a Project Team

Project Management Documents

Regulatory Documents

Regulatory Documents in Clinical Trials

Delegation of Authority Log – DOAL

Investigators Brochure (IB)

Trial Master File

Essential Regulatory Documents Binder Tab Organization (Trial Master File)

Trial Master File Reference Guide

New Drug Application

The Investigational New Drug (IND) & New Drug Application (NDA) Process

Investigator Initiated Multi-Center Trials

IND and IDE AE Reporting

Safety Reporting Requirements for Sponsor Investigators of An IND

Problem Solving in Project Management

Problem Solving as a Project Manager

Project Failures and Statistics

Project Reporting Styles

Avoiding Project Failure

Budgeting for Clinical Trials and Projects

Project Budgeting

Payments and Budgeting for Investigators and Site

Advertisement Aid in Subject Recruitment and Retention

Clinical Trial Design

Advanced Designs of Clinical Trials

Advanced Review of Phases of Clinical Trials (Preclinical & Phase 0-4)

Randomized Controlled Trials (Randomization, Allocation Concealment, Validity, Blinding, Controls, Outcomes, Fidelity)

Blinding and Unblinding in Clinical Trials

The Clinical Trial Protocol - Advanced Mastery Review

Inclusion and Exclusion Criteria in Clinical Research (Writing, Assessing for Broad vs. Narrow, Organ Dysfunction, Older Adults, Pediatrics, Pregnant Women)

Protocol Deviations and Violations (Major, Minor, Exceptions, Resolution)

Project Management Scheduling and Tracking

Basics of Project Scheduling

Project Progress Tracking

Project Management Planning Process

Project Management Plan

Closing a Project

Project Delays

Process Mapping

Metric Tracking

Duties of a Successful Project Manager

Roles and Responsibilties of a Project Manager

Project Management Success Factors

Adverse Events

Advanced Review of Adverse Events

Site Selection and Visits

Types of Monitoring Visits (Selection, Initiation, Routine, Close-Out)

Site and Investigator Selection Criteria (Process, Criteria, Investigator Selection, Agreements, Decision-Making)

Site Selection/Qualification Pre-Study Visit (SSV/SQV) (Before, During, After, Letters, Checklists, and Report)

Audit and Inspections

Audits and Inspections in Clinical Trials

Clinical Trial Data Audits

FDA Warning Letter

Quality Control and Safety

Quality Control in Clinical Trials ( QC/QA, KQI, QMS, Checklist)

ICH GCP - Safety of Human Subjects in Clinical Research

Technology in Trials (IVRS, CTMS, EDC)

Clinical Trial Management System-CTMS

ICH GCP - Trial Management, Data Handling, and Record Keeping

An Overview of Remote Monitoring - COVID-19 Update

Centralized Monitoring

Interactive Response Technologies in Clinical Trials (IVRS, IWRS, IRT, RTSM)

Pharmacovigilance and Regulatory Affairs

Advanced Practice of Pharmacovigilance

Regulatory Affairs for Clinical Trials

Investigational Product and Labs

Investigational Product Storage and Dispensing

Investigational Product Accountability in Clinical Trials

Local and Central Labs in Clinical Trials (Local, Regional, Central, GLCP, CLIA Cert, Lab Audit Checklist)

Patient Recruitment, Retention, and Compliance

Patient Recruitment in Clinical Trials

Patient Engagement and Retention in Clinical Trials

Patient Adherence and Compliance in Clinical Trials

Project Manager Job Readiness

Project Manager Skills Interview Questions

Interview Questions

Competency Examination

Competency Exam

About this course

• Required: Prior clinical research or project management experience.
• Length: 100 hours. Online, self paced, start anytime.
• ACCRE, Joint Accreditation with AMA, ANCC, ACPE for 17.5 CME. Online certificate. Exam score 70% or higher on 2 attempts.

Enroll Schedule Advising

CCRPS Reviews

Clinical Research Project Manager Certification

Navigating the Course

Natalie johnson.

I was originally intimidated by the materials and all that I had to learn. The syllabus, the instructors and the course material were easy to follow and lear...

I was originally intimidated by the materials and all that I had to learn. The syllabus, the instructors and the course material were easy to follow and learn from. I am very happy I completed the course.

Advanced Clinical Research Project Manager Certification ...

Roger andersen.

There is extensive material in this course. It is highly relevant to managing clinical trials.

Advanced Clinical Research Project Manager

Ellen lyrtzis.

The clinical trial project manager is responsible for different aspects of the clinical trial process, such as setting timelines, developing budgets, and overseeing data analysis. To become a clinical trial manager, you can gain experience in project management or clinical research roles. Clinical trial manager certification will increase your chances of getting hired.

To become a clinical project manager, one must first obtain a Bachelor's degree in a health-related field. Additionally, developing skills for project management and participating in relevant courses are necessary.

Experience can be gained by volunteering or interning in clinical trials with pharmaceutical companies or medical research centers.

Pursuing an advanced degree or getting certified as a Clinical Project Manager with open up more opportunities.

Clinical Trial Manager

Clinical Trial Managers are responsible for planning and overseeing all aspects of clinical research projects. This includes making sure the project is conducted according to regulations and best practices. They also manage budgets, timelines, and resources to ensure the project is completed successfully.

Clinical Project Managers plan and execute clinical research projects by coordinating with internal and external stakeholders, regulatory authorities, and by develop key documents like protocols, consent forms, investigator brochures, budget sheets, study reports, and final reports.

Clinical Research Manager

Clinical Research Managers make sure that data is being collected and analyzed correctly, and that everyone is compliant. Clinical Project Managers design research studies and monitoring projects in terms of cost, budgeting, quality assurance, and risk assessment.

The Clinical Trials Management Certificate program is designed to provide students with the knowledge and skills necessary to design, implement, and manage clinical trial protocols.

This Clinical Trials Design & Management Certificate Program introduces learners to the fundamentals of clinical trials design and management.

The program covers principles and regulations of clinical trial design, analysis techniques for statistical analysis, quality control and assurance, data management and reporting.

Students will also gain an understanding of risk assessment strategies, study site selection, protocol implementation and monitoring, resource management as well as safety requirements for conducting clinical trials.

Clinical Trial Manager Salary

Clinical manager salary.

Clinical trial manager salaries vary based on experience, location, and company size. The average hourly rate for a clinical trial manager is $30-$60 per hour.

Clinical trial manager salary

The monthly salary of a clinical trial manager typically ranges from $5,000 to $10,000. Those with more experience or who work at well-known organizations can earn up to $20,000 per month.

Clinical project manager salary

Annual clinical project manager salary ranges between $60,000 and $120,000 dollars per year. The median salary for a clinical trial manager is approximately $82,500 across all industries and geographies

What does a Research Project Manager do?

Clinical Project Managers are responsible for creating project plans, timelines, budgets, and communication with vendors and stakeholders. They also provide training to personnel involved in the project, establish systems to track project progress, and identify risks associated with the project.

Clinical Project Managers make sure that clinical research projects go well by working groups like contract research organizations (CROs), internal departments, and external vendors. Clinical Project Managers make sure that projects follow the research protocols, good clinical practices (GCPs), applicable regulations, and standards.

Research Project Managers also develop protocols for data collection and analysis, prepare reports for regulatory submissions, coordinate activities related to safety monitoring, and provide support to staff during project-related training sessions or workshops.

Trial Project Managers make sure that data is collected accurately according to guidelines from the FDA or EMA. This includes finding risks associated with the project; assessing their impacts; planning ways to reduce the risks; and also planning how to use resources so that everything runs smoothly.

The most advanced clinical trial project management training available

Take the fast track.

Take the fast track to a lucrative career as a Clinical Research Project Manager to start earning salaries of $100k+

Get advanced training

Get the most advanced training - ACRPM is recognized as a gold standard by many CROs in the industry thanks to its comprehensive training

Work at your own pace

Work at your own pace from wherever you are with flexible online training. The 100+ modules included can be completed in as little as 2 weeks

Requirements

Designed for those holding a minimum of a BA in Science, ACRPM is internationally accredited to ACCRE, ACCME, ACPE, ANCC, and Transcelerate Biopharma. In other words, upon completion of the course and the final exam, you will have a level of knowledge equivalent to (and beyond!) that of a senior CRA.

ACRPM features 100+ modules, or 250 hours, of on-demand online training (worth 17.5 CME credits). The course has been put together by clinical trial project managers, enabling students to build a deep knowledge of the industry.

Certification

This course can be completed in as little as two weeks, with certification and a letter of recommendation awarded after completing a final exam. ACRPM also provides you with tools to help you find a job, including resume and interview guides, giving you a further edge over other applicants for the same position.

Clinical Project Manager Guide

Clinical Project Managers are responsible for clinical research activities and initiatives in the healthcare, pharmaceutical, and biotechnology sectors. This includes creating and implementing project plans, developing timelines, overseeing budgets, managing resources, and ensuring compliance with regulatory requirements. CPMs typically work with cross-functional teams that may include clinicians, scientists, regulatory affairs specialists, data management personnel, software developers/engineers, project sponsors/coordinators.

The career path of a Clinical Research Project Manager is very rewarding. You get to use your clinical research expertise to develop new treatments for existing medical conditions and to create new treatments for future medical needs. Additionally, you get to work with leading doctors, scientists, and other professionals who are working towards improving healthcare outcomes. You also have the opportunity to build relationships with key stakeholders including pharmaceutical companies, governmental agencies, and funding bodies which leads to greater satisfaction in your career.

Research project managers are responsible for planning and executing research studies throughout their entire life cycle. This includes activities such as designing experiments or surveys, selecting appropriate experimental methods or sampling techniques, recruiting participants for studies or surveys, collecting data from multiple sources, analyzing results using statistical methods or software programs, interpreting results and preparing recommendations for further action.

The clinical project manager definition refers to a professional who is in charge of developing clinical research activities from the beginning to the end. This includes making a plan for the scope and timeline of the research project; making sure that the project meets all regulatory requirements; organizing the technical aspects of data collection; coordinating meetings between stakeholders; monitoring progress and deadlines; utilizing risk management processes; providing guidance to staff members; ensuring quality control of data collection processes; providing reports to stakeholders and company executives regarding project status updates as needed.

Working as a clinical project manager can be challenging due to the complexity of the tasks involved. Clinical projects require significant planning, coordination and supervision between multiple stakeholders. Additionally, time management can be difficult due to deadlines that must be met and ever-changing regulatory requirements. Other challenges include managing competing priorities and ensuring proper communication between team members. It is also important for clinical project managers to stay current on trends, technologies and best practices within their field so that they can remain competitive in their work.

The core duties of a clinical project manager vary depending on the industry but typically include planning and organizing activities related to assigned projects; developing budgets; coordinating resources; monitoring progress; overseeing quality control standards; ensuring adherence to safety procedures; providing leadership for teams; communicating with stakeholders throughout the duration of the project; developing plans for corrective action if needed; preparing reports for upper management; analyzing data related to performance metrics; maintaining records of all activities related to assigned projects; and staying informed of changes in regulations relating to their area of expertise.

To be a good clinical project manager, it is important to have experience working in healthcare, like in a hospital. It is also helpful to be good at organizing and communicating, as well as understanding the medical environment and the rules that govern it. Additionally, clinical project managers should know about principles related to project management, like budgeting, scheduling, and risk management. Those who have earned a healthcare-related degree or certificate (like in nursing or health information management) may have a better chance of being successful in the role.

A clinical project manager oversees clinical research studies from design through implementation. This includes working with teams of physicians, pharmacists, nurses, statisticians or other health professionals. Responsibilities include making sure the project runs smoothly while staying within the budget and timeline. As part of their role they must understand FDA regulations when conducting trials in the US or ICH guidelines when conducting international studies. Additionally they must be able to identify potential risks associated with each study and develop strategies for mitigating them throughout all stages of the study process.

The average salary for a Clinical Project Manager is approximately $85,000 per year. Hourly pay for Clinical Project Managers usually ranges from around $41 to $58 per hour, with an average rate of approximately $49.50 per hour. Monthly salaries typically range from around $7,083 to $9,833 per month or more.

•Clinical Project Manager – Research and Development: This person is responsible for making sure clinical research studies are organized and run smoothly. • Senior Clinical Project Manager: This person provides guidance to project teams and management when they are developing clinical research projects. • Global Clinical Trial Program Manager: This person creates global clinical trial plans that meet operational requirements while following regulatory guidelines. • Clinical Data Management Project Manager: This person oversees all aspects of data collection, management, analysis and reporting associated with a clinical research project from start to finish. • Regulatory Affairs/Clinical Project Manager: monitors and reports on the regulatory submissions for clinical trials taking place in different countries. • Clinical Operations Project Manager:: oversees and coordinates the daily operations of clinical research projects to ensure that they meet quality assurance standards set out by IRBs or FDA .

Achieving certification as a Clinical Project Manager is a way to show that you are an expert in project management within the healthcare and medical research industries. This certification allows individuals to demonstrate their understanding of clinical project management concepts and skills, which are necessary for ensuring successful outcomes for initiatives within complex clinical research environments. To obtain a Clinical Project Manager Certification, you need extensive knowledge and experience in clinical project management, which can be obtained through formal education, training courses, and hands-on experience.

Certification as a clinical project manager provides healthcare professionals with the skills and knowledge necessary to effectively manage complex clinical trials, research projects, and quality improvement initiatives. There are several key reasons to get certified, including professional credibility, a competitive edge in the job market, increased knowledge base, improved efficiency in completing tasks related to clinical project management, and networking opportunities.

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Clinical research project management: back to basics.

Clinical trials require care and precision regarding planning, coordination, and collaboration. The stakes are high, with participants’ health and well-being and significant investments of both time and money on the line. That’s why clinical research project managers are necessary – to ensure coordinated and collaborative efforts between numerous departments, teams, and vendors that adhere to the study protocol as well as regulatory and ethical standards. In this article, we will take an in-depth look at the basics of clinical research project management.

What is project management in clinical research?

Clinical trials involve several complex, dynamic parts with different boundaries/areas of responsibility, and personnel with specific skill sets and qualifications. As a consequence, successful clinical trials require organizers who are adept at project management.

Clinical trials can be thought of as large-scale, complex projects with multiple milestones and parallel workstreams, including:

• Study and protocol design
• Study startup
• Site activation
• Recruitment
• Documentation (promotional material, informed consent forms, case report forms, protocol documents, surveys, etc.)
• IRB and IEC approval
• Site management
• Investigational product distribution and management of study materials
• Laboratories (analyses, lab tests, imaging, etc.)
• Reporting and regulatory affairs

Why is project management in clinical research important?

Clinical research involves multiple stakeholders. Project management can essentially be thought of as monitoring progress and keeping everyone involved on the same page. Project management is critical for the success of a clinical trial; it helps the different teams stay on schedule, adhere to protocol, and communicate amongst one another, as well as meet the trial objectives/targets, maintain quality standards, stay within budget, and follow regulatory requirements.

The following are three major reasons why project management in clinical research is important:

Timeline management

Project management ensures the delivery of clinical trial objectives and sub-objectives within the allocated time and budget. This is important because nearly 85% of all clinical trials experience delays. [1] Project management techniques can allow investigators to plan ahead if it looks like a deadline is not going to be met, so they can reallocate resources and priorities to accelerate the process, or otherwise notify teams responsible for tasks that would be affected by the resultant delay and adjust the timelines.

Streamline and facilitate communications

It is important for the various stakeholders involved in a clinical trial to be on the same page. Keeping all of these actors updated and facilitating communication amongst them is another task of the project management team. Lack of communication in clinical trials can have negative consequences on the quality of research. [2] An efficient project manager or management team can streamline communication and collaboration between multiple teams and departments, further increasing the transparency of the individual but interdependent operations.

Quality control (QC)

Quality control is another important aspect of clinical research project management. Quality standards are often stringent, but this is designed to protect the safety of participants and the general population. Clinical trials that fail to adhere to or meet quality standards will not be considered to have provided sufficient evidence on the effectiveness and/or safety of an investigational drug. Researchers and investigators tend to be under a lot of pressure as trials are often on tight budgets and timelines, but it is important that quality not be sacrificed in order to meet other objectives.

Project management helps sponsors/investigators manage all objectives and sub-tasks in a clinical trial while still prioritizing adherence to quality and regulatory standards. Part of the task of the project management team may even be to define internal quality standards for specific tasks, objectives, and/or teams.

What does a clinical research project manager do?

A clinical research project manager coordinates with other departments, teams, and personnel involved in the clinical trial to ensure the organized completion of clearly defined tasks. They also manage external vendors such as central laboratories or technology providers. Project managers will monitor the progress of all tasks and objectives to keep the study on track according to its protocol, including timeline and budget, and also communicate with stakeholders such as the sponsor to keep them up to date.

What is the clinical research project manager responsible for?

The responsibilities of a clinical research project manager depend on the specifics of the trial and its complexity, but they generally include the following:

• Planning : This includes general planning of the trial, including the internal organization between departments/teams, how tasks should be executed in order to comply with regulations, how many and which sites to involve, whether external tools/solutions need to be contracted, etc.
• Budgeting : Making sure that the study’s resources are allocated appropriately to the different teams/tasks, within the overall study budget, also providing room for unexpected costs or delays.
• Vendor identification/selection : Negotiation with vendors, technology providers, and suppliers.
• Scheduling : Scheduling the objectives/sub-tasks of the clinical trial and monitoring activities to make sure they are completed on time.
• Liaising : Acting as a central point of contact for members of the project team and sponsors.
• Task delegation : Assigning tasks to team members and updating them about their responsibilities, as well as deadlines and expectations.

What are the key topics included in a clinical research project plan?

The project manager may organize all of the above-mentioned tasks and responsibilities into a document or repository referred to as a clinical research project plan. This plan would formally outline standard protocols for aspects of the clinical research project management, such as:

• Timeline : The timeline should clearly outline specific tasks for each team/department, including their expected initiation and completion dates, and the project manager will ensure tasks and teams are on track. Clinical trials often get delayed, so it is useful to have protocols in place regarding how to deal with potential delays. [3]
• Budget : Often related to unexpected delays, it is not uncommon for projects to end up over budget. The project plan should clearly define budgets, both for teams and for individual tasks, and should outline how deviations from budgets should be dealt with.
• Stakeholder management : The project management plan should outline the content and dates of formal reports for keeping stakeholders updated about the trial’s progress.
• Documentation : The project plan should outline how documentation should be collected, organized, stored, and verified in order to ensure compliance with laws as well as ethical and clinical standards as established by the WHO and ICH guidelines for Clinical Good Practice.
• Site management : Although site monitoring is usually a separate responsibility in clinical trials, the project plan may include instructions and guidelines for individual study sites regarding adherence to protocol, tasks, and timelines. In addition, sites should have clear guidelines on who to contact in the case of any problems, questions, or adverse events that may arise during the trial.
• Data management : The project plan should specify protocol for the collection, secure storage, management, validation, and cleaning of subject information and trial data, in accordance with quality standards and applicable regulations. Proper data management ties in closely with quality assurance, and sound results require healthy data.

Tips for successful clinical research project planning and management

Here are 4 specific tips and ideas for maximizing the efficacy of project management functions in clinical research.

1. Plan with flexibility

Delays can be hard to avoid, especially in the recruitment stage, and they are costly to sponsors. Nonetheless, proper consideration of these potential delays in the timeline (i.e., allowing for some degree of flexibility) can make the difference between the delays simply setting the trial back a few weeks, or ending in the entire trial being canceled.

While delays aren’t ideal, proper planning can allow the sponsors to absorb these delays without them leading to completely missed deadlines and/or cancellation of the trial; in the end, cancellation likely represents a much more significant waste of resources than delays. The same logic can be applied to flexibility in budgeting, as delays may imply additional costs; if these are less unexpected, they can be better absorbed within the trial budget without setting it entirely off track.

2. Identify possible risks and establish mitigation strategies

Perform a thorough analysis of the protocol and utilize specialist knowledge in the fields of medicine and clinical research management to identify and create a list of risks that could arise throughout the clinical trial. Planning ahead of time will allow sponsors to respond rapidly to these risk factors and mitigate them, without having to perform lengthy analyses and coming up with mitigation strategies when it may be too late.

Some potential risks to consider include recruitment delays or low accrual, adverse events, patient dropouts, protocol breaches, problems with study drug supply or distribution, technical failures (of software systems, medical equipment, etc.), and data integrity issues, to name a few. Start with the risks that pose the greatest threat to the integrity of the study, i.e., those which would result in it being canceled, stopped, or rendering the results unusable.

3. Use project management tools

Constantly reviewing all aspects of the clinical trial is a daunting task, so the use of specialized and customizable software solutions can be helpful. There are many such solutions available, from general project management tools to dedicated clinical trial management systems ( CTMS ). These tools can be of significant help in managing, organizing, and overviewing all of the aspects of project management discussed previously, acting as a sort of central dashboard as well as a “safeguard” for the project management plan and tasks.

4. Leverage data automation tools and functions

Similarly to the previous point, data management is another aspect of clinical trials (and clinical trial project management) that can benefit greatly from the assistance of technological tools. Lots of data management functions, including organization, cleanup, and validation, can be streamlined or even completely automated through data processing tools, which are sometimes integrated directly into CTMS or other clinical trial monitoring solutions. The benefits of healthy data include enhanced regulatory compliance and faster progression to data analysis and results once the study data has been collected. Data can also be improved at the source through the use of electronic reporting/collection/recording methods such as:

• Electronic patient-reported outcomes ( ePRO )
• Electronic trial master files ( eTMF )
• Electronic clinical outcome assessments ( eCOA )
• Electronic case report forms ( eCRF )

Conclusions

Clinical research project management is a vital function for keeping the numerous separate yet highly interconnected parts involved in a clinical trial operating in coordination and on track with protocol, budget, timelines, and regulations. There are numerous strategies and tools that can facilitate clinical trial project management tasks and help improve clinical trial quality and speed while still ensuring patient safety and regulatory compliance.

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What Does a Clinical Project Manger Do? Roles & Responsibilities

Clinical Project Managers (CPM) play a crucial role in advancing the progress of a clinical trial. The significance of CPMs lies in their ability to navigate complex clinical trials, ensuring precision, compliance, and efficiency.

As stewards of the entire research lifecycle, from planning to execution, Clinical Project Managers wield strategic thinking, leadership insight, and a deep understanding of regulatory landscapes.

In a world where the pursuit of groundbreaking therapies intensifies, the demand for skilled managers is reaching new heights, with organizations recognizing their pivotal role in trial success. 

This blog explores the pivotal responsibilities of clinical project managers and sheds light on why their expertise is becoming increasingly coveted, underscoring the crucial role they play in shaping the future of healthcare.

Table of Contents:

What is a Clinical Project Manager?

What does a clinical project manager do, skills required to become a clinical project manager.

• Essential Certifications or Degrees Required to become a Clinical Project Manager

How to Become a Clinical Project Manager?

Salary and job outlook for a clinical project manager.

A Clinical Project Manager (CPM) is an experienced expert in clinical research and healthcare management who is responsible for managing and coordinating the different aspects of clinical trials.

This multifaceted role encompasses strategic planning, execution, and monitoring of clinical research projects to ensure they adhere to regulatory standards, timelines, and budgets.

Clinical Project Manager acts as a connecting point between research teams, sponsors, regulatory authorities, and other stakeholders, facilitating effective communication and collaboration. 

Clinical Project Manager responsibilities include protocol development, risk management , team leadership, and navigating the complexities of regulatory compliance. By leveraging their expertise in project management, scientific understanding, and regulatory knowledge, they contribute significantly to successful clinical trials, ultimately advancing medical knowledge and bringing novel treatments to needy patients.

A Clinical Project Manager (CPM) is a pivotal figure in clinical trials, overseeing the intricate processes that lead to the successful execution of healthcare research. Their role encompasses many responsibilities, blending scientific expertise with project management skills to ensure the seamless progression of clinical trials.

Other key roles and responsibilities of a Clinical Project Manager:

• Strategic Planning: Develop comprehensive plans for the initiation, execution, and completion of clinical trials, aligning them with project goals and timelines
• Protocol Development: Contribute to the creation and refinement of study protocols, outlining the methodology, objectives, and criteria for participant selection
• Site Selection: Identify and evaluate suitable clinical trial sites, considering factors such as patient demographics, facilities, and regulatory compliance
• Regulatory Compliance: Navigate and ensure adherence to the complex web of regulatory requirements, obtaining necessary approvals and permissions for the clinical trial
• Budget Oversight: Manage the financial aspects of the clinical trial, ensuring adherence to the allocated budget and making informed decisions to optimize resource utilization
• Data Integrity: Oversee data collection and management processes, emphasizing the importance of data accuracy, completeness, and compliance with regulatory standards
• Problem Resolution: Address challenges and obstacles that may arise during the trial, making decisions that safeguard patient safety and ensure the integrity of the study
• Quality Assurance: Maintain a focus on the overall quality of the clinical trial, implementing measures to uphold ethical standards, patient welfare, and the reliability of research outcomes

Becoming a successful clinical project manager requires a diverse set of skills that combines scientific knowledge, project management proficiency, and effective communication. Below are some of the key skills that a clinical project manager is required to excel in the role:

1. Project Management Skills

• Planning and Organization: Ability to develop and execute comprehensive project plans, ensuring all aspects of the clinical trial are well-coordinated
• Time Management: Efficiently allocate resources, manage timelines, and prioritize tasks to meet project milestones
• Risk Management: Identify potential risks and proactively implement strategies to mitigate them, ensuring smooth project progression

2. Scientific Understanding Skills

• Clinical Research Knowledge: Familiarity with the principles and processes of clinical research, including study design, protocols, and ethical considerations
• Medical Terminology: Ability to understand and interpret medical and scientific terminology crucial for effective communication with research teams and stakeholders

3. Communication Skills

• Interpersonal Communication: Build strong professional relationships with diverse stakeholders , including research teams, sponsors, regulatory authorities, and site personnel
• Presentation Skills: Effectively convey complex information clearly and concisely, verbally and in written form

4. Leadership and Team Management Skills

• Team Building: Foster collaboration and cohesion within cross-functional teams, inspiring motivation and commitment to project goals
• Decision-Making: Make informed decisions promptly, especially in high-pressure situations, to address challenges and keep the project on track

5. Regulatory Knowledge and Skills

• Regulatory Compliance: Stay updated on and ensure adherence to relevant regulations and guidelines governing clinical trials in different regions
• Ethical Considerations: Understand and navigate the ethical considerations in clinical research, prioritizing patient safety and welfare

6. Problem-Solving Skills

• Critical Thinking: Analyze complex situations, identify root causes of issues, and develop effective solutions to keep the project moving forward

7. Financial Acumen

• Budget Management: Proficiency in managing project budgets, optimizing resource allocation, and ensuring financial accountability throughout the trial

8. Adaptability Skills

• Flexibility: Navigate unforeseen challenges and changes in project scope with adaptability, adjusting strategies and plans as needed
• Learning Agility: Stay abreast of advancements in clinical research, project management methodologies, and regulatory requirements

Essential Certifications or Degrees Required to Become a Clinical Project Manager

Becoming a Clinical Project Manager requires a combination of education, relevant degrees, and professional certifications. The specific requirements may vary based on the employer, industry sector, and the clinical trials complexity.

Here are some essential certifications and degrees that can enhance the qualifications of individuals aspiring to become Clinical Project Managers:

1. Educational Background

• Bachelor’s Degree: A bachelor’s degree in an appropriate field such as life sciences, healthcare, nursing, pharmacy, or a related discipline is frequently the minimum educational requirement
• Advanced Degrees: While not always mandatory, having a master’s degree (e.g., Master of Public Health, Master of Science in Clinical Research) or a Ph.D. can be advantageous, especially for more senior or specialized roles

2. Project Management Professional (PMP) Certification

The PMP certification is offered by the Project Management Institute (PMI), is widely recognized, and demonstrates proficiency in project management principles. It is valuable for Clinical Project Managers as they oversee complex clinical trials.

Achieve global recognition with the PMP certification from Invensis Learning. Benefit from expert trainers, flexible learning options, and success guarantees to propel your career to new heights. Enroll now to access exclusive discounts and become a certified leader in project management.

3. Certified Clinical Research Professional (CCRP) Certification

The Certified Clinical Research Professional (CCRP) certification is a professional designation offered by the Society of Clinical Research Associates (SoCRA). It is a worldwide recognized credential that demonstrates an individual’s skills and understanding of the principles and practices of clinical research.

4. Project Management Fundamentals (PMF) Certification

The Project Management Fundamentals (PMF) Certification is an entry-level credential offered by the Association for Project Management (APM) that validates an individual’s understanding of the fundamental principles and practices of project management. It is designed for those new to the field or wanting to formalize their project management knowledge.

5. Certified Clinical Project Manager (CCPM) Certification

The Certified Clinical Project Manager (CCPM) certification is a professional designation offered by various organizations that demonstrates an individual’s expertise in managing clinical trials and research projects. It validates their ability to effectively plan, execute, monitor, and evaluate clinical research studies, ensuring adherence to regulatory and ethical guidelines.

Becoming a Clinical Project Manager involves a strategic combination of education, experience, and professional development. Here’s a step-by-step guide on how to embark on a career as a Clinical Project Manager:

1. Get a Bachelor’s and a Master’s Degree

Embark on your journey by earning a bachelor’s degree in a relevant field, such as life sciences or healthcare. This foundational step equips you with essential knowledge for a career in clinical research.

To enhance your qualifications further, pursue a master’s degree, opting for specialized programs like a Master’s in Public Health (MPH) or a Master’s in Clinical Research.

2. Opt for an Entry-level Clinical Job

Kickstart your career with an entry-level position in clinical research, such as a Clinical Research Assistant or Coordinator. These roles expose you to the day-to-day operations of clinical trials, providing valuable insights into research protocols, data management, and regulatory compliance.

3. Gain Clinical Research Experience

Actively seek hands-on experience in clinical research, engaging in tasks like patient recruitment and study coordination. Develop a strong understanding of Good Clinical Practice (GCP) guidelines and ethical considerations. This practical experience lays the groundwork for a well-rounded skill set and prepares you for more advanced roles.

4. Build a Strong Resume

Create an effective resume that highlights your educational background, relevant coursework, and practical experience. Emphasize key skills such as attention to detail, data management, and knowledge of regulatory standards. Include certifications, like GCP, to underscore your commitment to maintaining high-quality standards in clinical research.

5. Find a Position as a Clinical Project Manager

Progress in your career by applying for roles with increasing responsibilities, focusing on project management within clinical trials. Leverage your educational background, practical experience, and certifications to showcase readiness for a Clinical Project Manager role. Highlight your ability to lead teams, manage timelines, and strictly adhere to regulatory standards.

Before switching any career, individuals should know two main things: one is salary growth and the other one is job opportunities. The salary and job outlook for a Clinical Project Manager (CPM) can vary based on factors such as experience, education, location, and the specific industry within healthcare or clinical research. It’s essential to note that salary trends and job outlook may evolve over time.

Salary of a Clinical Project Manager

The salary prospects for a clinical project manager are generally quite positive. They play a crucial role in the healthcare industry, overseeing the planning, execution, and monitoring of clinical trials and research projects.

Their expertise in project management, clinical research methodology, and regulatory compliance ensures the successful completion of these studies, leading to the development of new drugs, treatments, and medical devices.

Experience is a significant factor in determining salary. The salary ranges for clinical project managers are as follows:

Clinical project managers have the potential to experience significant salary growth throughout their careers. With increasing experience, specialized skills, and advanced certifications, clinical project managers can advance into senior-level positions with higher earning potential.

Additionally, the demand for clinical project managers is expected to grow faster than average in the coming years, further contributing to positive salary prospects.

Job Outlook of a Clinical Project Manager

The job outlook for clinical project managers is exceptionally promising, driven by the increasing demand for clinical trials, the growing complexity of research projects, and the expanding healthcare needs of an aging population.

As per the US Bureau of Labor Statistics (BLS) , employment of medical and health services managers, which includes clinical project managers, will expand by 32% from 2020 to 2030, much faster than the average for all professions. This growth is related to the aging population and the increasing demand for healthcare services.

Here are some specific factors that contribute to the positive job outlook for clinical project managers:

• Increasing demand for clinical trials
• Growing complexity of clinical trials
• The aging population and rising healthcare needs
• Expansion of medical group practices

Clinical project managers can pursue diverse career paths and advance into senior-level positions with increasing responsibilities and higher compensation.

Some potential career trajectories include:

• Clinical Research Associate (CRA)
• Clinical Research Coordinator
• Clinical Research Manager
• Director of Clinical Research
• Clinical Research Program Manager
• Clinical Research Portfolio Manager
• Clinical Project Manager Specialist
• Clinical Project Manager Lead
• Global Clinical Project Manager
• Senior Clinical Project Manager
• Executive Clinical Project Manager

A clinical project manager plays a pivotal role in the healthcare industry, ensuring the successful execution of clinical trials and research projects. Their expertise in project management, clinical research methodology, and regulatory compliance is crucial for bringing new drugs, devices, and therapies to patients, improving healthcare outcomes, and advancing medical knowledge.

If you are passionate about healthcare, have strong organizational skills, and possess a keen eye for detail, a career as a clinical project manager could be a rewarding and fulfilling path. With the right education, experience, and certifications, you can significantly impact the future of healthcare by overseeing the development of life-saving treatments and technologies.

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Clinical Trials

Inside a CRO: The Essential Role of a Clinical Project Manager

Lindsey Pierce

What is a Project Manager’s role in a clinical trial?

Clinical trials are the backbone of drug development, ensuring that new treatments are both safe and effective. In this intricate process, the Clinical Project Manager stands as a linchpin, ensuring the seamless execution of these trials.

Pharmaceutical and biotech companies who hire a Clinical Project Manager from Precision for Medicine gain a dedicated professional who ensures timely delivery, budget adherence, and risk mitigation, all while maintaining the highest standards of clinical research.

What makes for an effective Clinical Project Manager?

A Clinical Project Manager, often abbreviated as PM, brings a unique blend of skills and expertise to the table:

• Strong attention to detail and organization:   Ensuring every aspect of the trial is meticulously planned and executed.
• Ability to track multiple deadlines and budgets:   Keeping the trial on track financially and temporally.
• Team leadership and collaboration abilities:   Unifying diverse teams towards a common goal.
• Excellent communication and interpersonal abilities:   Bridging the gap between sponsors, teams, and other stakeholders.
• Problem-solving and decision-making skills:   Navigating challenges that arise during the trial.
• Adaptability:   Meeting the diverse needs and personalities of team members.
• Comfort in challenging situations:   Handling difficult internal and client conversations with tact and professionalism.

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What are the responsibilities of a Clinical Project Manager?

A PM’s responsibilities span the entire lifecycle of a clinical trial, ensuring every phase is executed to perfection.

Pre-award responsibilities

• Supporting bidding and defense conversations to win the clinical trial.
• Informing on bid strategies, including sites, patient enrollment, and overarching strategies.
• Helping finalization of scope conversations, leading to clinical trial contract.

Responsibilities during study start-up

• Contributing to the review and finalization of the trial protocol and related documents.
• Creating the project plan and building the timeline.
• Assembling the study team into a cohesive unit.
• Assessing and recommending study vendors (if applicable for Sponsor at this stage).
• Projecting patient enrollment and evaluating study timeline impact.

Responsibilities during the trial

• Monitoring resourcing needs throughout the course of a trial.
• Managing the trial budget and ensuring vendor success.
• Recommending investigational sites and overseeing site activation timelines.
• Reviewing and tracking risks for study timeline delivery, implementing risk mitigation strategies.
• Ensuring quality data collection, protocol adherence, and patient safety.
• Maintaining proper documentation practices for audit readiness.
• Driving issue resolution and continuous process improvements.

Trial close-out responsibilities

• Managing study closeout and ensuring the archival of study-specific documents.
• Overseeing delivery of a clean and complete Trial Master File (TMF).
• Coordinating the Clinical Study Report.
• Evaluating final budget deliverables and ensuring all costs have been reconciled.

From study-start to finish: Journey of a Clinical Project Manager

Ensuring client satisfaction in communication and documentation

During the trial, the PM plays a pivotal role in maintaining a harmonious relationship between the CRO and the Sponsor. This is achieved by:

• Developing budgets and additional timelines that are realistic yet aggressive.
• Proactively identifying potential delays and out-of-scope work.
• Implementing proactive and reactive study challenge mitigations to keep the trial on track.
• Forecasting work to evaluate the remaining budget of the study.
• Motivating team members and investigators towards trial goals.
• Ensuring all study communication and documentation has been filed in the Trial Master File.
• Proactively identifying resourcing needs or gaps.
• Aligning trial conduct with sponsor strategic objectives.
• Maintaining constant communication with the sponsor to ensure client satisfaction and study team improvement.

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• Dec 13, ‘22

Clinical Project Managers are indispensable in balancing the health of a clinical study and ensuring its success. Their expertise, dedication, and meticulous approach ensure that drugs are brought to market efficiently, benefiting the industry as a whole and, most importantly, the patients awaiting new treatments.

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The Clinical Research Project Management Association (CRPM) was established to bring together clinical research professionals who utilize project management tools and methodologies to assist them in achieving project deliverables on time and within budget.

CRPM aims to connect members of the Clinical Research Project Management (CRPM) community through online groups, in-person meet-ups, monthly webinars, and retreats for project managers that target expanding the CRPM network throughout the clinical research industry.

CRPM strives to educate the CRPM community through professional and career development opportunities including articles, webinars, and in-person events to empower CRPMs with the skills and education needed to perform their roles efficiently and effectively.

CRPM is dedicated to improving the health, both mental and physical, of CRPMs in our community. CRPM is dedicated to seeing CRPMs as a whole person, not a productivity tool, which includes supporting the physical and mental wellness of CRPMs in a demanding career field. Health and wellness topics will be featured throughout the various platforms used in the CRPM community to support CRPMs

CRPM aspires to provide a space that helps CRPMs grow personally and professionally in their careers, recognizing that their success depends on a balanced approach to both their work and personal lives.

Vision of CRPM

CRPM envisions a future where Clinical Research Project Managers (CRPMs) have access to a supportive community that provides the resources, education, and tools needed to succeed in their careers. We are committed to promoting the health and wellness of our members, recognizing that their success depends on a balanced approach to both their work and personal lives. CRPM aims to foster a vibrant community of CRPMs that prioritize personal and professional growth while achieving a healthy and sustainable lifestyle.

The CRPM is a community of clinical research professionals dedicated to expanding our knowledge in project management and clinical research. We strive to connect CRPMs through a range of platforms, including online groups, in-person meet-ups, monthly webinars, and retreats, to expand the CRPM network throughout the clinical research industry. We are committed to promoting the health and wellness of our community, recognizing that the success of CRPMs depends on taking care of the whole individual.

CRPM Advisory Council

The Advisory Council for CRPM is a group of experienced and respected individuals in the clinical research industry who provide guidance and support to the organization’s leadership team. Members of the Advisory Council are selected based on their expertise in clinical research project management, healthcare, academia, and business.

The role of the Advisory Council is to provide strategic advice to the CRPM leadership team on matters related to the organization’s goals, mission, and vision. Council members also serve as ambassadors for CRPM, promoting the organization’s mission and objectives within their respective networks and industries.

Through regular communication and collaboration with the CRPM leadership team, the Advisory Council helps to ensure that the organization is well-positioned to meet the needs of its members and to advance the field of clinical research project management.

CRPM Members

CRPM Membership is open to clinical research professionals who utilize project management tools and methodologies to assist them in achieving project deliverables on time and within budget. Members gain the skills, knowledge, and connections needed to excel in their roles and advance their careers through exclusive educational and career development opportunities, networking events, industry news, and resources. CRPM members also have access to a variety of online resources, including webinars, forums, and other tools designed to help them stay informed and up-to-date on the latest trends and best practices in clinical research project management.

Learn more about CRPM Membership .

CRPM Volunteers

Volunteering with CRPM provides clinical research project managers with the opportunity to give back to the profession, connect with like-minded professionals, and gain valuable experience and skills that can help them advance their careers. Volunteers have the chance to make a meaningful contribution to the field of clinical research project management, helping to shape the industry’s future.

Learn more about Volunteering with CRPM .

CRPM Ambassadors

CRPM Ambassadors are members of the CRPM community who are passionate about the organization’s mission and goals and want to help spread the word about CRPM within their networks and beyond.

As a CRPM Ambassador, members act as advocates for the organization, sharing information about CRPM with their colleagues, friends, and other contacts. CRPM Ambassadors play an important role in helping the organization grow and expand its reach within the clinical research project management community.

Learn more about CRPM Ambassadors .

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What to know about project management for clinical trials.

Completing any multi-part task requires organization, coordination, and discipline — and, of course, clinical trials are no exeption. Planning a research study, launching a trial, and keeping things running smoothly requires knowledge and expertise, which is why clinical trial project managers are so vital to the process.

From creating a plan, communicating updates, calculating risks, and addressing any mistakes that arise , solid project management is a necessity to ensure medical research is allowed to move forward. Here, we’ll discuss the role of the clinical trial project manager, as well as tips for developing project plans, stakeholder involvement, communication, IRB submission, and summarizing lessons learned.

What is project management in clinical trials?

The Project Management Institute (PMI) defines project management as the "application of knowledge, skills, tools, and techniques to project activities to meet the project requirements." Project management combines expertise in scope, time, cost, quality, risk management, communication, and stakeholder management in order to move through the five basic phases of any project :

• Project initiation. This phase involves developing an idea, understanding the necessity of the project, and identifying the key decision-makers
• Project planning. This is the phase for making a plan and outlining the work required, including prioritization, budget, schedule, and resources
• Project execution. This is where tasks are distributed by informing all teams of their responsibilities and deadlines
• Project monitoring. This entails implementing project tracking to compare the current project status and progress with the original plan, adjusting as needed
• Project closure. The final phase, where project managers reflect on project success and key learnings for next time

When concerning clinical trials, project management brings all of these phases together to ensure set up, enrollment, operations, and reporting are all done smoothly and effectively. 

Roles of a clinical trial project manager

A clinical trial project manager may have different responsibilities specific to each trial, but in general, they will be tasked with vendor selection, budget oversight, IRB submissions, report creation, and meeting planning, all of which are detailed below.

Vendor selection: Because conducting a clinical trial requires many different elements, outside vendors will often be brought in to provide expertise in certain aspects of a study. This is most common for specialized elements such as Interactive Web Response Systems (IWRS) , electronic patient-reported outcome (ePRO) technology, and clinical trial patient recruitment . Often, it will be the project manager's job to vet these vendors and assist with comparing options.

Timeline and budget oversight: Though every study begins with a specific timeline and budget, nearly 80% of all clinical trials are delayed due to difficulties in patient recruitment, which causes many to exceed their budget. In these situations, a project manager can leverage their expertise to hold the trial team accountable for the time and money spent on the study, in addition to managing expectations should these elements begin to change. 

IRB submissions: Any patient-facing materials involved in research studies must be reviewed and submitted for Institutional Review Board (IRB) approval, and gathering these materials is often the responsibility of the clinical trial project manager. Because every IRB is different, the project manager will need to look at previous submissions and any templates that are available to ensure the study's particular IRB requirements are met.

Report generation: As part of tracking the progress of a trial, clinical trial project managers should regularly generate and distribute reports on various aspects of a study’s progress. These reports can often be automated so they are not a time-consuming task, but they do play an essential role in keeping key stakeholders looped in on the progress of the research.

Meeting coordination: Occasionally, the trial’s key stakeholders may need to meet to review a trial’s progress and address any roadblocks. The project manager will likely be charged with planning and leading these meetings to ensure that all details are covered and relevant updates are provided.

Tips for effective project management in clinical trials

Create a detailed project plan

One of the best ways to circumvent delays and issues in a clinical trial is to create a detailed project plan before the study launches. This plan should include a timeline of milestones, key dates, a task schedule, and any other relevant pieces that can keep the project on track. Some people may prefer pen and paper for this, but there are also many online resources available to help project managers keep track of details and stay on schedule.

Anticipate risk management demands

Every project will have some level of risk, so it’s wise to acknowledge what points of contention may arise and plan accordingly. A few examples of risks associated with clinical trials include:

• Long wait times for IRB approval
• Delays in patient recruitment
• Turnover among site staff
• Changes to the trial protocol

Before the project starts, it can be helpful to come together as a team to discuss potential risks that may arise, share past experiences, and determine how they can be prevented or handled if they do arise.

Understand IRB requirements

In most studies, the project manager will also be tasked with gathering materials and submitting them for approval from the Institutional Review Board (IRB). Every IRB will vary on its guidelines, but IRB administrators should be able to answer any questions to ensure a smooth and efficient process.

Even if the responsibility of IRB submission is a task for the project manager, it can be helpful to enlist additional team members to provide a second set of eyes before the materials are submitted. It is also wise to create a checklist of elements that should be included in the IRB packet to ensure nothing gets left out.

Foster open communication between sites and sponsors

Another important communication piece for project managers is to share feedback from sites back with the sponsor of the trial. Communication is particularly important in relation to sharing updates with sponsors about recruitment or screening challenges the site may be facing. 

Communication tips for project management

One of the most important jobs of a clinical trial project manager is to ensure clear and effective communication with multiple stakeholders. To manage this communication from the onset, it can be useful to create a list of stakeholders, the updates they'll need, and how often they should be informed.

To manage this communication, the RACI project management method can provide a helpful framework to organize stakeholders into four categories based on their involvement in the project and communication needs.

• Responsible: The responsible party is the main point person for communication – this is the stakeholder who does the actual work of this part of the project. For example, when submitting outreach material to the IRB, the person responsible for creating the material may be the lead on the marketing team or the contact at a clinical trial recruitment company.
• Accountable: The accountable person is generally the manager of the responsible party and may wish to be involved in only some of the updates related to the project. Generally, if the responsible party needs approval from their manager, they should do so before sharing updates more broadly.
• Consulted: The consulted party would be any additional stakeholders who should weigh in on a project. The responsible or accountable party can generally help project managers determine who should be involved in the consultation.
• Informed: These are people who are simply kept up-to-date on the progress of the project at appropriate intervals.

A paper on managing clinical trials published by the National Institutes of Health also mentions the importance of keeping the investigators themselves in the loop about a trial, stating, "Investigators need to feel valued and part of an inclusive team answering an important clinical question, so providing regular feedback that ensures they feel involved must be central to a trial's communication strategy." Because the investigators may also have busy clinical practices in addition to being part of the trial, it’s important to respect their time while making them feel involved and informed.

Project managers’ roles after a clinical trial

Project management is an ever-evolving skill and there are lessons to be learned from even the most successful project execution. It’s important that project managers evaluate each trial after it's complete in order to analyze trends and plan for the next one while key learnings are still top of mind. As Hubspot puts it, "a productive project post-mortem is a chance to fully unpack a project's trajectory and dig deeper into why things unfolded the way they did.”

Hosting a project post-mortem meeting involving key stakeholders is advisable. Sending a pre-meeting questionnaire can streamline the process of gathering thoughts on what went well, what didn't, and what could be done better next time. The agenda should include a recap of the project's goals and a review of the results so that any discrepancies can be addressed and everyone is able to come up with actionable takeaways for the future.

If you're interested in learning more about how Antidote begins the clinical trial recruitment process and manages the project throughout, download our recruitment template below.

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Project Management In Clinical Trials: Practical 2024 Guide

If you’re new to project management in clinical trials, this guide will help you understand what it means to be a project manager on a clinical trial, and then provide some practical tips to help you plan and manage your clinical trial effectively.

• Struggling to effectively manage timelines and budgets in clinical trial projects?
• Feeling overwhelmed by the complexity of regulatory requirements and documentation?
• Unsure how to navigate communication challenges between stakeholders?

This article is for:

• Clinical trial project managers seeking practical strategies for streamlining processes and maximizing efficiency.
• Researchers and coordinators looking to enhance their understanding of project management principles in the context of clinical trials.
• Pharmaceutical and biotech professionals interested in improving trial outcomes through effective project management techniques.

Project Management in Clinical Trials: How Does It Work?

As a Project Manager, you may need to be prepared to manage client expectations from day one and will be responsible for managing resources and relationships with internal and external parties. As a Project Manager, your main job function is to get projects completed on time.

The importance of your role means that you will have regular contact with senior stakeholders across all functions in an organization and therefore be highly visible within your organization. You will ensure your team is focused on building long-term relationships that benefit both parties; being able to build good relationships quickly will allow you a high level of engagement with key stakeholders.

Good project management in clinical trials requires a detailed understanding of business procedures, being aware of commercial and strategic priorities, and an awareness of key performance indicators and trends. The key areas of expertise for clinical trial project managers are communication, relationships, influence, planning, attention to detail, and following instructions.

Strong teamwork skills are also essential when working on projects as well as people management skills. You will need to be adaptable to a rapidly changing environment with diverse cultures; you will also be required to negotiate successfully with stakeholders at all levels.

Being an effective project manager in clinical trials is a challenging but fulfilling role. As well as being rewarded with great job satisfaction, you may find your salary increases significantly as you gain experience. However, like any other profession, there are challenges associated with being a clinical trial project manager and you will need to be emotionally resilient when dealing with change.

Common problems include:

• Rapidly changing priorities and unrealistic expectations of resources
• Internal conflict between team members
• Dealing with stressful situations on a daily basis such as late deliveries or looming deadlines
• Having limited influence over projects due to numerous stakeholders who have input on projects being assigned to your team

You will need to be able to organize tasks based on deadlines, manage staff resource allocation, and work with your team members to ensure projects are completed on time. It is essential that you listen to client requirements when managing your project. Your team will look to you for guidance in difficult situations and as such, it is vital that you have excellent communication skills. You will also be required to report project status information throughout a project lifecycle as well as performance against specific objectives, these metrics can be used by management in evaluating staff effectiveness.

Tips for a Clinical Project Manager

Clinical project manager is one of those jobs that, like teaching or parenting, requires a different set of skills and approaches. Among other things, it requires project management.

So what makes managing clinical research projects different from any other sort of project?

Well, in order to begin answering that question let’s first look at what makes any sort of project management different from regular life. In short, it is knowing your resources and being able to apply them towards meeting goals.

Here are some things that a clinical project manager should keep in mind:

• Having a solid budget and a clear schedule for every step of your project.
• Having effective methods for team communication, as well as leadership from above.
• Working with expert subject matter consultants to make sure that your plans are effective and reliable.

There are many other tips for being a good clinical project manager, but these are some of the biggest in terms of avoiding common pitfalls or conflicts in project management methodology. If you want to be successful in your job, know what resources you have access to and how they can be used most effectively.

Don’t forget to consider tips that are specific to project management in clinical trials. These might be more limited, but they can be equally important for your team. For example, working with regulatory bodies is a critical part of any clinical trial, but understanding how to navigate their complex structure and meet their expectations can be a challenge for even experienced project managers.

Good project management for clinical trials is an essential part of a successful research process. Having a clear plan from start to finish, as well as qualified personnel, can help you to avoid common pitfalls and make sure that your project comes in on time and within budget. And there are many more tips and tricks that you can use when you need to work with regulatory bodies or coordinate teams of expert consultants. Remember that just because something seems different doesn’t mean it has to be overwhelming. Use good project management techniques to keep your focus on what matters most: getting results!

How to run effective meetings with your team members

One of the most important aspects of project management for clinical trials are effective meetings. No matter how efficient your team members are, if they’re not meeting regularly, then it’s going to be difficult to keep projects on schedule and ensure that everyone knows what’s going on at all times. Effective meetings help to solve problems quickly, identify potential issues before they become major roadblocks and keep everyone moving forward with their work. The key is to hold effective meetings consistently, meetings are only useful if they’re regularly scheduled and if people feel comfortable discussing what needs to be discussed.

Pick a meeting location and schedule that works for everyone on your team. Meetings are only useful if they’re easy to get to and scheduled at a time when everyone can attend. Try to avoid scheduling too many meetings all at once as it can become overwhelming. Likewise, try not to schedule them at times when people are likely to be focused on work that isn’t directly related. People need time in their day to focus on other tasks and don’t want unrelated matters distracting them from what they need to be doing.

Follow these tips to help keep your meetings effective:

• Make sure that everyone is on time for meetings.
• If someone is late, you might need to reschedule so that they can come and discuss whatever it was.
• Be sure to start and end meetings on time.
• It’s also a good idea to have a meeting go-round. It is a great way to make sure that everyone has had an opportunity to talk about their topics during meetings. How often you do go-rounds depends on how many people are in your meetings. It is best not to waste too much time talking over each other just because there are more people present.

Keeping your team informed about the clinical trial

Keeping a clinical trial team informed on a daily basis is key to success. There’s just too much going on during these types of projects to not communicate regularly with your team members and update them on all their responsibilities and deliverables. A good project manager will be able to keep stakeholders informed with reports and will keep team members informed with notes or individual emails.

As new information comes in, the project manager can quickly and easily relay it to everyone involved in a timely manner. That type of communication helps ensure you aren’t wasting time answering basic questions again and again or waiting for important feedback from someone who isn’t aware of what’s happening.

An example of an effective way to keep stakeholders informed is with regular emails and reports. Project managers who are taking part in a clinical trial should receive updates and relevant information on a daily basis, so they can distribute it to their teams as needed. This keeps everyone informed while reducing back-and-forth communication and helps reduce confusion.

As a clinical project manager, you may also be asked to help keep patients informed about their participation in a trial. This type of communication with patients is generally conducted through phone calls or emails and depends on how long they have been participating in that trial. For more information on your role as a project manager when it comes to patient communication and retention, check out some helpful resources from Clinical Trials Arena .

Project management principles in clinical trials

Just like in any other business, planning and management are key to a successful clinical trial. A good manager should set clear goals, organize resources and delegate tasks so that all team members are clear on their responsibilities. They should also facilitate communication among team members, look for opportunities to make improvements, and be proactive with regards to potential issues.

We know what you’re thinking: your scientific skills have little to do with project management—but there’s truth in that statement only if you think of management as supervising every aspect of your study yourself. Think of it instead as simply facilitating effective teamwork so everyone involved is aware of what their role is and how they can best contribute toward achieving success.

A good project manager will also recognize that there are different types of clinical trials, each with their own set of challenges. For example, a drug study will have its own specific regulatory requirements and an investigation into new medical devices may involve equipment and electronic record keeping.

The clinical trial project manager should discuss these factors at length with their team so that everyone involved knows what to expect and is prepared for any hiccups along the way. This will ultimately lead to a smoother process overall—especially if you’re conducting your research over several years—and allow you to make better use of valuable time and resources.

It is important to always think ahead. It might be tempting to take a day off when you’re tired, but doing so can really set you back in your work. For example, if you’re a clinical project manager and decide not to come into work one day because of fatigue, that could leave your team shorthanded for a couple of days—which may mean that testing has to be postponed for weeks or months. Not only does that mean your research will take longer than anticipated, but also you may find yourself running up against regulatory deadlines later on down the line which are much harder to meet with a short timeframe. The Project Management Institute has a page dedicated to clinical trial information for additional information.

What is a clinical trial project plan?

The specific deliverables and timelines of a project plan are based on what an individual project manager expects to accomplish. A single clinical trial can take years, so having concrete milestones and deliverables with exact timing is essential for project management in clinical trials. Project managers will often develop detailed, line-by-line schedules that map out a year or more of tasks and related deadlines. Major milestones can include everything from identifying sites and recruiting participants to regulatory submission requirements or final approval of study results by ethics committees. Project managers in clinical trials will work closely with other members of research teams—from technicians performing experiments to doctors who conduct examinations—to ensure their efforts remain on track.

Many project managers in clinical trials will also develop detailed budgets for their projects, mapping out how much time and money is being spent on each step of research. Tracking costs from day one can help a project manager avoid major costs down the line. Even simple errors can end up costing hundreds of thousands or even millions of dollars over an extended project timeline.

A detailed budget will help an experienced project manager identify opportunities to save money while still keeping their project on schedule and within its budget, ensuring that study efforts don’t experience any major bottlenecks. As with any other kind of project management work, it is vital to ensure that your clinical trial has assigned resources at every step.

You can also see why project management in clinical trials is needed: multiple research groups, vast amounts of money and costly resources, many moving parts. And because clinical trial projects are often funded by pharmaceutical companies or other entities with a financial stake in study results, having a designated project manager with expertise in study design and patient recruitment will ensure that everyone on your team is working to improve your end product: better drugs for patients. By hiring an experienced project manager for your clinical trial—or doing everything yourself if you have enough time and expertise—you can ensure that all study efforts move along smoothly, ending with actionable results for drug companies looking to bring safe new treatments to market.

How do you get into clinical trials project management?

When looking for a job in clinical trials project management, it is best to apply to organizations within your geographical area as you may then be able to take on part time work while you are learning on-the-job. Once you have gained experience and achieved success with projects, you can apply for full time jobs with other organizations.

Alternatively, you may wish to work for yourself or set up your own company if there is a gap in the market for your services; however, running your own business does require additional skills. If becoming self employed interests you, be aware that it will require commitment and hard work to succeed but being self employed allows flexibility so if working away from home is important to you then taking on additional freelance projects could suit.

Another way to gain experience is to do internships or clinical research assistant work. Aspiring project managers in clinical trials will find that a lot of trial management jobs require some previous experience and it can be difficult for new graduates to find roles but internships give students an opportunity to try out roles within clinical trials without making a long term commitment; they also make it easier for employers who may not otherwise take on new graduates to take them on as interns are short term and low-risk commitments.

If you would like to be a project manager in clinical trials, then you should consider your strengths and abilities. Consider what subjects you enjoyed studying at school and university and think about what skills or qualities you have that could make you a good project manager in clinical trials.

Think about what personal characteristics would help in your role; for example, extroverts may find it easier to liaise with other departments, whereas conscientious people may perform better at planning. Keep an eye out for job adverts on job boards or visit healthcare organizations to ask if they are looking for project managers. This is also a good way of meeting people who work within clinical trials and gaining more contacts.

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21 Research project management

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What is a project? - Stage 1: Definition: defining and agreeing what the project is about - Stage 2: Planning: planning how the project will be conducted - Stage 3: Implementation and control: running the project - Stage 4: Close out: delivery and the end of the project

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With a 30-year legacy, acrp certification is the most reputable credentialing program in clinical research. since 1992, more than 40,000 professionals and their employers have come to trust acrp certification as the mark of excellence in clinical research., “joining acrp and becoming certified was the best thing i ever did to jumpstart my career in research and has opened many doors for me.”, jeri burr, ms, rn, ped-bc, ccra, facrp acrp certified since 1999, benefits of certification >, start your next career journey by exploring acrp’s flagship certification and subspecialty credential programs below. each program provides specific information and resources on exam eligibility, exam content, how to apply, scheduling & testing, how to prepare, and after your test. if you have questions, explore the faq page or the acrp certification handbook ., acrp certified professional, acrp-cp ® is a credential formally recognizing clinical research professionals of all types, regardless of their roles or functional activities on the clinical study team., learn more >, certified clinical research associate, ccra ® is a credential formally recognizing clinical research professionals with experience monitoring and supervising the conduct and progress of clinical trials on behalf of a sponsor., certified clinical research coordinator, ccrc ® is a credential formally recognizing clinical research professionals with experience coordinating and facilitating clinical trial activities in adherence to gcp, under the direction of a principal investigator., certified principal investigator, cpi ® is a credential formally recognizing clinical research professionals with experience as a principal investigator or sub investigator on multiple studies., acrp medical device professional, acrp-mdp ® is a credential formally recognizing clinical research professionals with specialized knowledge in medical device clinical trials. candidates must be acrp certified to sit for this exam., acrp project manager, acrp-pm ® is a credential formally recognizing clinical research professionals with specialized knowledge in project management. candidates must be acrp certified to sit for this exam., the academy’s acrp-cp, ccrc, ccra, and cpi programs are accredited by the  national commission for certifying agencies (ncca),  which sets internationally recognized standards for the development and operation of certification programs. the standards assure that a program is valid, reflects current practice, and treats candidates fairly and are based on the established processes for developing certification exams., the most respected certification thought leaders in the country agree that ncca accreditation is the gold standard when it comes to accreditation of programs that certify professionals working in healthcare—including the clinical research industry. when you’re searching for certification programs, make sure you always look for the ncca-accredited program seal., bring certification to your team —acrp certification is an ideal solution for managers looking to enhance team knowledge, grow leaders, and signify to others that their study teams are among the best of the best. learn more >.

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Effective Project Management of Clinical Trials

Feature article.

During medical school or post graduate training, we receive some formal training in designing and running complex programs like research projects or clinical trials. For those interested in clinical research, we then spend years learning how to ask good research questions, draft research protocols, apply correct research methodology and write successful grant applications.

Following this path, I was lucky to secure a grant and start a pilot clinical trial involving 30 patients. I thought I had all the right tools, time and resources to successfully conduct this project. However, I soon realized the painful reality of managing a clinical trial – it is incredibly challenging! I encountered multiple early failures like slow recruitment, lack of team coordination and overall inefficiency. It dawned on me that at no point during my clinical career had I received formal training in project management. A project management expert helped me navigate this challenge. In this article, I share my insights on project management not only for clinical trials but also for any type of project requiring the coordination of a team and resources around a specific objective.

Pearl #1: Project management of clinical trials is a science with valuable tools at your disposal. We tend to think the day-to-day business of managing a clinical trial is not the "scientific part." However, project management is a science and has well-defined evidence-based methods. Recognizing this is the first step in successfully managing clinical trials. Learning to harness the power of these tools is the second step. Using tools like chunking , GANTT charts , and resource allocation will organize and simplify the flow of your trial.

Pearl #2: Focus more on human aspects as compared to technical aspects. There are two major aspects of any large project: the technical and the human. As trained scientists, we tend to take the rational approach: "If I have two research nurses available and I am paying for 60% of their full time equivalent from my grant, then they will work whole-heartedly for three days per week on my project and I will finish this project in three months."

The root cause of inefficiency in my clinical trial was not technical, it was me ignoring the "human-side." I was fixated on productivity but overlooked the people working with me – my team. I realized that regardless of the resources and planning, it is the human element that drives successful project management.

• Grow the Team Leader: Building a better team always starts with building a better team leader. Inspiring your team with your hard work, work ethic, compassion, empathy and leading by example can ensure a long-lasting relationship even in challenging times. "Leading means that others willingly follow you – not because they have to, not because they are paid to, but because they want to." – Simon Sinek.
• Know your team: Ask, "What motivates my team to conduct research?" "What is their background, their perspective?" Have an honest conversation and get to know the person behind the title. For example, what motivates those trainees to volunteer their 80-hour work week and sacrifice their weekends to your project? What sparks the interest of your research nurses? Is it just a job requirement or are they passionate about the science? What are your team members' expectations? Answers to these questions will help you build a motivated, hard-working team. "A team is not a group of people that work together. A team is a group of people that trust each other." – Simon Sinek.
• Rapport building: Showing interest in your team member's life not only at work but also outside work helps to create a stronger relationship. While we have multiple project meetings where we discuss progress, timelines and feedback, taking an interest in the person behind the job is essential. Asking about their family, hobbies and how their weekend was is enough to create a connection. A big part of being a scientist is being a good friendly human being first.
• Feedback: It is important to get feedback from team members and always get their input on how to improve workflow and identify gaps between your expectations and their perception. It provides the opportunity to look at things from their perspective and realize their challenges.

Conclusion Project management coaching made me realize that although I was technically competent, I was ignoring the human element of my clinical trial. What did I change? I got to know my team members as individuals. I discovered what motivated each one of them and we worked together to align their roles in light of their strengths and interests. They were helpful in suggesting several quality improvements to the project and our overall workflow and efficiency was much better. I went from frazzled to effectively managing my first clinical trial.

In the end, real life is a lot messier than a mathematical equation. To successfully move a project, program or trial forward, designing it is not enough: plan using the right tools, keep your key stakeholders motivated and informed, and channel your energy into growing a solid team.

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This article was co-authored by Zain Asad, MD, Fellow in Training (FIT) at the University of Oklahoma in Oklahoma City, OK, and Kat Niewiadomska, PhD, ACC Member Leadership Development associate.

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Project Management: Guides to the Basics

Project management tools and principals are used successfully in business to manage goals and objectives to meet expectations of deliverables: product quality, timelines and cost.   We in research know how complicated it is to get from “idea” to completed study publication.   Experience shows us project management skills and tools can help streamline the research process and use your time more effectively through a planned, methodical approach;  a little like applying the scientific method to study start-up, recruitment, study conduct and closure!

Our four modules (15 minutes a day) provide an introduction to the basics of project management with skills, tools and local resources you can use immediately.

Additional Project Management Resources

If, after finishing our  Project Management: Guides to the Basics series, you want to learn more about the discipline of project management, consider these courses:

Project Management for Clinical Research Professionals – ACRP

Project Management Certificate Program – DIA

Project Management Certificate Program – the Pharmaceutical Education & Research Institute

Project Management Professional Certification – The Project Management Institute

Postgraduate Certificate in Clinical Trial Management – Parexel

30-Hour Clinical Project Management Fundamentals Certification Program – Barnett International

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Project Management

According to the Business Dictionary (2010),  ‘project management’  is  organisation of work within time, budget and cost limits . A bad project manager, therefore, can be defined as a manager who is unable to arrange project work according to some or all of these constraints. The reasons for this may be a PM’s lack of experience/knowledge or skills and poor communication between concerned parties (which is also due to insufficient training, SOPs, lack of experience or inability to account for previous failures and success).

As highlighted by Rettig, R.A. (2000, p.129), the importance of project management and oversight is crucial in the environment of prevailing commercial approach in pharmaceutical industry. Though it may be safer for Pharma to manage their own R&D projects internally, it becomes more time- and cost-effective to outsource clinical trial and pre-approval activities to specialized CROs. However, it is true that quality of project management services delivered by CROs is often unsatisfactory due to different reasons (Bryde, D.J. and Joby, R., 2007). Among other reasons for such outcome the authors cite the view of British Standards Institute (2003), according to which project management is a service that must be of an appropriate quality, i.e. must satisfy all participating parties. However, projects (even very similar in many aspects) are also unique and, thus, require individual approach based on previous experience.

Indeed,  reasons for failure of a project  and most  significant elements of project success  can be defined as  symmetrical antipodes .  If one would define what a bad project manager could do wrong to cause a project failure, it is possible to   mention instead what a good project manager would do to make a project successful.  The most important elements of a successful project management are  Quality Assurance and project planning  at each step. So, to avoid problems in project management the following must be taken into account by project management team (or a PM):

Houston, S.M. & Bove, L.A. (2007):

• Consistent methodology
• Definition of a project by  limits of time, cost and performance  (OR by scope, cost and time)

EA RHA, 1993 cited in Caan, W., Wright, J. & Hampton-Matthews, S. (1997, p.468):

• Team  with sufficient  knowledge and training
• Support  and  back-up of the organisation

Wycoff, 1991 cited in Caan, W., Wright, J. & Hampton-Matthews, S. (1997, p.469):

• Knowledge that you, as a PM,  can achieve/facilitate achievement of the project            goals
• Planning:  a clear picture for all participants to describe the stage of the project, how  a certain goal was achieved and where/how to move further to reach further goals
• Utilization of project management frameworks, such as PRINCE  (EA RHA, 1993 cited in Caan, W., Wright, J. & Hampton-Matthews, S., 1997, p.469)
• Assessment and re-assessment of  risks = development and subsequent adjustment of the initial project plan

Besides, a good project manager would ask him/her-self the following questions and make the answers clear to other team members  (Caan, W., Wright, J. & Hampton-Matthews, S., 1997):

–          Why certain steps are maid =  what result is expected

–           What is required  for goals achievement

–          Who should do what and when:  Development of the Communication Plan

–          Whether everything needed is in place to start

–          When and whether the project is completed

–           What lessons have been learnt from this project

–           What can be done to improve further performance

So, to make a project successful a PM must: be experienced, have appropriate team and support, plan accordingly, communicate, make corrections, learn from previous mistakes/success, implement gained knowledge.

References:

Bryde, D.J. and Joby, R. (2007) ‘Importance of project and project management deliverables in clinical trials’ , R&D Management , 37(4), pp. 363-377.

Business Dictionary (2010)  Project Management  [Online]. Available from:  http://www.businessdictionary.com/definition/project-management.html .

Caan, W., Wright, J. & Hampton-Matthews, S. (1997) ‘Start as you mean to go on:  Project management for beginners’,  Journal of Mental Health , October, 6(5), pp. 467-472.

Houston, S.M. & Bove, L.A. (2007)  Project Management for Healthcare Informatics , Springer (New York), Chapter 1 ‘Project Management Process’, pp. 1-14 .

Rettig, R.A. (2000) ‘The Industrialisation of Clinical Research’,  Health Affairs , Vol 19, Issue 2, pp. 129-146.

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Barnett International's Core Curriculum courses are comprehensive role-based clinical research training programs designed to provide industry professionals with hands-on training in a dynamic virtual setting. Held four times a year during our “Clinical Research Training Weeks,” courses offer clinical research-focused, performance-based training and core competency development.

Clinical Project Management: Advanced Concepts in Project Management

Upcoming Courses

This course will be offered from 9:00 a.m. - 4:00 p.m. Eastern

This course will be offered from 12:00 p.m. - 7:00 p.m. Eastern

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Course Description

This two-day advanced course delves into advanced clinical research project management skills, mapped to the Project Management Institute, PMBOK ® 6th and 7th editions.  This course is recommended for the experienced clinical project manager with a minimum of three years of clinical project management experience. Advanced concepts are presented to explore how project managers effectively communicate and lead project teams to overcome complex issues, including prioritizing project needs, influencing and leading project teams and stakeholders.  The course also covers challenges in vendor lifecycle management, project risk assessment (project, quality), and issues management. All concepts are presented in a dynamic, interactive manner to facilitate learning and retention.

Learning Objectives

• Explain project management tools and principles used in clinical trials
• Formulate project priorities and approach to effectively manage project needs
• Develop effective communication and leadership skills for the project needs
• Identify critical to quality factors and risks in clinical trial project
• Appraise effective stakeholder and vendor management in clinical trials
• Describe effective leadership skills in leading project teams

Who Should Attend

• Project Managers
• Clinical Research Coordinators, Associates, Monitors, and Managers
• Regulatory, Medical, and Clinical Affairs Professionals

The course will be led by one of the following instructors:

Shelley Marti, M.S.N., P.M.P.

Danny Nasmyth-Miller, B.A. (Hons), M.B.A.

Nazma M. Rosado, MAOL, P.M.P., CPLP, 6σ, CMQ/OE

Click here for complete trainer biographies

Course Outline

• Introduction: Review of clinical project charter, project plan, project risk analysis, and use of various tracking methods in project management
• Importance of the Project Team: Your team is the key to project success
• Prioritization Management: Priority setting to manage project schedule and workload
• Managing Projects: Stakeholder management and effectively leading/directing/influencing project teams
• Project Risk and Critical to Quality Factors: ICH GCP E6 (R3) and ICH E8 (R1) in the conduct and management of a clinical trial
• Project Vendor Management and Oversight:  Ensuring successful vendor oversight and issue management

Interactive Activities

• Case Study: Prioritization management for the clinical project manager and effective delegation
• Case Study: Stakeholder identification, interests, and considerations for effective management
• Discussion: Effective leadership skills, per the topic or situation encountered
• Case Study: Identify project risks and implement a treatment plan
• Case Study: Stakeholder and vendor management

Registration Fees

Special rates are available for multiple attendees from the same organization.  Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for more information. Or email Customer Service at: [email protected].

Click here for our seminar cancellation policy

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-24-003-L99-P. Released: 3/24.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.

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Clinical Research Project/Program Management Conference

Unlock the art and science of clinical trial project and program management with this immersive workshop. Whether you're diving into this dynamic field or seeking to enhance your expertise, this program is designed to introduce, affirm, or elevate your understanding of project management in the field of clinical research. Delve into the regulatory landscape and refine your skills in planning, administering, tracking, evaluating and budgeting through engaging discussions and interactive sessions. 

October 17 & 18, 2024 | Philadelphia, PA

Four Points Sheraton Philadelphia City Center Hotel   1201 Race Street Philadelphia, Pennsylvania 19107

Hotel Phone: 215-496-2700 Reservations: 215-496-2700 Or ONLINE

SOCRA hotel room rate of $229 USD (Includes resort fee), plus applicable taxes, is available until October 2, 2024 or until the room block is filled. You must mention SOCRA to receive room rate. 

May 8 & 9, 2025 | Savannah, GA

The DeSoto 15 East Liberty Street Savannah, GA, 31401

Hotel Phone: (912) 232-9000 Reservations: 1-855-703-4655 or Book Online

SOCRA hotel room rate of $229 USD (Includes resort fee), plus applicable taxes, is available until April 7, 2025 or until the room block is filled. You must mention SOCRA to receive room rate. 

Registration Fees:

• Member Fee - $655
• Non-Member Fee - $730 Non-Member Fees include a non-refundable one-year membership in SOCRA

Continuing Education Credit Hours:

SOCRA designates this educational activity for a maximum of 14.25 Continuing Education Credits for SOCRA CE and Nurse CNE. SOCRA designates this live activity for a maximum of 14.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Accreditation Statements:

CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center's Commission on Accreditation.

SOCRA Course Series: 250

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