Certified Clinical Project Manager (CCPM)

**Awarded by the Project Management Committee at the Clinical Research Society**

The ability of a Clinical Trial Project Manager to manage all aspects of a clinical trial significantly impacts the time and cost taken to develop a drug or medical device. It is important that a Clinical Trial Project Manager is a well-rounded individual. They will be required to have a high set of skills, tools and knowledge that is proficient in clinical research. Any candidate that wants to be considered for this position must have a formal university degree of four or more years obtained either on-campus or via an online mode.
Some of the best project managers hold degrees that aren’t directly related to clinical research but are centered around health care. Individuals with an MBBS, BDS, DDS, M.Pharm, or an
MPH degree
are perfect examples of individuals who are passionate about developing new drugs or medical devices that will benefit the public. This allows project management professionals to efficiently lead the trial outcome from the start of the project. A Project Manager must also have the ability to appropriately act, respond and adapt to developing situations during a clinical trial.

The CCPM certification evaluates the ability of the applicant to adapt and apply concepts and principles to successfully achieve desired project objectives and goals. CCPM Certification provides for a detailed assessment of the application of knowledge, skills, tools, methods, standards, and best practices in clinical research project management thus enabling clinical trials to be safe and efficient.

The CCPM certification examination is conducted regularly. After passing the certification examination the candidate is awarded  a designation of “Certified Clinical Project Manager (CCPM)” with a seal valid for 2 years.

Who Should Get Certified?

All Clinical Research Professionals who directly or indirectly manage clinical trial processes.

Whether you are working as a Clinical Research Associate, Clinical Study Manager, Project Manager, Project Coordinator, Clinical Logistic Manager or Project Lead, this certification will provide an assessment and certify the intensive experience and expertise you have acheived during your clinical research career.

Clinical Study Managers who are familiar with project management will attain higher skills and enhance their knowledge and understanding of how sponsor and CRO companies should efficiently and ethically drive clinical trials. Getting certified will be a major driver towards a more responsible and higher position in clinical research and allied industries.

Other Functional Specialists who will benefit from this certification are Medical Affairs Specialists, Pharmaceutical Development Scientists, Translational Medicine Specialists, Interdisciplinary Researchers etc.

Eligibility:

To be eligible for this certification program, applicants have to demonstrate a combination of educational background and  evidence of work experience in clinical research. The applicants must suffice  the eligibility requirements as per one of the categories listed in the table below:

View the Eligibility Table

CATEGORYEDUCATIONWORK EXPERIENCE - CORE CORE PM TASKS * (IN HOURS)DOCUMENTS REQUIRED (ALONG WITH APPLICATION
1
Bachelor's Degree OR
Master's Degree OR
Registered Nurse (RN)
2800
Detailed CV/Resume AND
Job Description
2
Bachelor's Degree OR
Master's Degree OR
Registered Nurse (RN) AND
Completion of an education program of more than 150 hours in clinical research
1400
Detailed CV/Resume AND
Job Description AND
Certificate of completion of clinical research education program
3
Associates Degree
4200
Detailed CV/Resume AND
Job Description
4
Associates Degree AND
Completion of an education program of more than 150 hours in clinical research
2800
Detailed CV/Resume AND
Job Description AND
Certificate of completion of clinical research education program
5
High School Diploma OR
LPN/LVN/Medical Assistant/ Research Assistant
5600
Detailed CV/Resume AND
Job Description
6
High School Diploma OR
LPN/LVN/Medical Assistant/ Research Assistant AND
Completion of an education program of more than 150 hours in clinical research
4200
Detailed CV/Resume AND
Job Description

CCPM Preparatory / Refresher Course

Preparatory / Refresher course for the Certified Clinical Project Manager (CCPM) examination covers the following main areas. Additional resources are provided. The training uses the Project Management Body of Knowledge (PMBOK®) as a guide so participants learn how to use  management strategies, tools and techniques to their clinical trial projects.:

01. Drug development process
02. Clinical Research
03. Understanding of project management terms
04. Role of the project manager
05. Project life cycle
06. Project scope and objective
07. Project constraints
08. Common and critical parameters needing management and tracking
09. Project planning methodology
10. Tools and Techniques for modifying the project plan
11. Feasibility studies, risk assessment, risk planning and management
12. Making a work breakdown structure, a task network and schedule
13. Additional Challenges with Global Trials
14. Project schedules and critical path analysis
15. Managing the project team
16. Communication and Stakeholder Management
17. Clinical Trials Timelines, Budgets, Resource Management & Scope Management
18. Project tracking and dealing with variance
19. Managing change
20. Project close-out

Certification Examination:

CRS has partnered with ProctorU to offer proctored exams for all Certification Programs. To ensure integrity, security & consistency of the examination process, real people oversee proctored exams. Proctored exams are a required component of the certification programs at CRS. You can schedule an examination at your convenience after registering for the exam and paying the examination fee of USD 27/-  on the CRS website. Scheduling of examinations with proctorU will not incur any additional cost unless the exam is scheduled within 3 days of the date of scheduling. The CCPM examination will be of 2 hours duration.

ProctorU allows individuals all over the world to take their exams online while ensuring academic integrity for the institution. ProctorU uses a three-step process to replicate the face-to-face proctoring experience over the Internet. Through this process, proctors can see the student, observe their computers, and know whom they are monitoring. ProctorU does this while adhering to the highest accreditation standards in the industry. ProctorU is a pioneer in the industry and serves close to 100 partnership institutions including Northwestern University, the University of Florida and the University of Illinois.  You can find more information on ProctorU here.

The Certification Examination is a mix of Multiple Choice Questions, Short Answer Type Questions and Case Studies.

While the training provided though our CCPM training program is extensive and broad in scope, members are nevertheless tested on their understanding  based upon other resources that he/she may have been directed to during their training. These resources may include the FDA website, international and/or local policies, regulations, and guidelines, best practices, etc. We provide an exhaustive list of such resources through our Learning & Certification Portal.

CCPM Training & Certification Fee:

For CRS Professional Members: USD 200/-

For CRS Non-Members: Fee varies between USD 300/- and USD 400/- based upon the nationality of the Non-Member.

Maintenance of Certification:

Certifications must be maintained every two (2) years from the time of original certification. Maintenance of certification requires the completion of 24 documented hours of activity. This can be achieved through the combination of accumulating credits through Continuing Research Education (CRE) AND/OR  accumulating credits through Continuing Professional Engagement (CPE). More information about maintenance of certification is available here.

The fee for maintenance of CCPM certification is USD 200/- every two years for CRS Professional Members (provided the membership is active) and varies between USD 300/- and USD 400/- every two years for Non members, based upon the nationality of the Non Member.

How to Apply?

CCPM certification is open both to Professional Members and Non-Members, provided the eligibility criteria stated above are fully met. To register for the CCPM certification program, please select your CRS Member Status below and fill up the application form. Upon submission of your application and receipt of applicable fee your application will be processed by the CRS Project Management Committee. We may request more documentation than is asked for in the application form. If you are already a CRS Professional Member please keep your membership number handy.
 

 

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