Clinical Research Project Manager – Overview
Clinical research project managers play an important role in keeping clinical trials on track and under budget.
While some may consider clinical project research management as a soft skill, in reality, it is an extremely complicated discipline that can become more advantageous with the right formal training.
If you’re planning to become a clinical project manager (CPM) it is crucial to understand the essential skills and experience needed for becoming a successful research project manager.
What are the responsibilities of a Clinical Research Project Manager?
As a clinical research project manager, your main job involves planning and managing everything related to a clinical trial.
Research trials are aimed at evaluating the effectiveness and safety of medicinal drugs, devices and in-vitro diagnostic techniques. All these combine to support marketing claims or regulatory submissions.
For a clinical trial to be successful, a CPM needs to manage a team of Clinical Specialists and Clinical Research Associates (CRA). The CPM is the common point between clinical trial sites and study sponsors.
Successful CPMs understand the intricacies of project management techniques. This is incredibly important to lead a multi-disciplinary research team. Ideally, a CPM should also have the capacity for leadership.
This is because their responsibilities may involve training the team, evaluating staff performance and helping resolve issues with the clinical trial.
Additionally, CPMs also need to have excellent communication skills. This way, a CPM can create and sustain relationships with investigators, sponsors and research staff with equal ease.
When you get promoted to CPM from a CRA, the writing and analytical skills you gain as a CRA are also crucial to know for a CPM.
Experienced CPMs are also expected to have sufficient knowledge of the financial aspects of research studies. This includes knowing everything about invoice reviewing, regular accounting tasks and creating a feasible budget for the research trial.
In some cases, a CPM may also be required to participate in statistical analysis and creating data documentation which is essential for registration, approval and marketing clearance.
What is the Career Scope for Clinical Research Project Manager?
There is an incredible demand for CPMs not just in the US, but also abroad in numerous countries. As global regulations on clinical trials become stringent, there is an increasing demand for successful and experienced clinical project managers.
As a CPM, you can choose to work in numerous different industrial niches. Your job prospects may include working in companies that make pharmaceutical drugs, medical devices or in-vitro diagnostic equipment.
Your will mainly deal with managing the trial study or supervise a clinical research project.
In addition, CPMs can also work for academic institutions or non-profit healthcare-centric organizations as the lead for clinical research projects.
How to become a Clinical Research Project Manager?
There is no particular set of academic qualifications that are required to become a clinical research project manager. C
PMs can come from a variety of educational fields and backgrounds. Usually, you need to acquire a bachelor’s degree in science, such as life sciences, health, bioengineering or biology.
If you have advanced educational qualifications, such as MS, PhD, MBA or MD it becomes easier to enter the medical research industry. However, you also need to have relevant project management and clinical trial experience along with these educational qualifications.
Candidates who are also adept at writing scientific documents such as study protocols have an added edge over their peers.
As a CPM, you will be expected to work in high-pressure environments. Hence, you should have significant knowledge of Good Clinical Practice and similar regulatory requirements.
If you have previously worked with IRB (Institutional Review Board) or EC (Ethics Committee) then this is highly valuable.
In general, a CRA with around 7 to 9 years of experience is considered to be an ideal candidate for becoming a successful CPM.
How to apply for a CPM job?
You will need to make sure that your CV shows your previous relevant experience clearly. Make sure to highlight your relevant experience with clinical trials and your contribution towards achieving the study objectives.
If your CV is well-organized and error-free then this also acts to your advantage because it shows that you have an eye for detail. This is a crucial aspect for a successful clinical project leader.
A simple Google search will help you to find job opportunities for CPMs nearest to you, or give you the most relevant job openings in your field of choice.