As job titles or descriptions go, “Project Manager” leaves a lot of room open for interpretation. You’ll find it applied to people’s roles in all sorts of industries and organizations, and it may mean very different things from one setting to another. So what makes being a project manager so unique in the context of the clinical research enterprise, where you’ll most likely find them working directly for sponsors, or based within contract research organizations (CROs), or operating as independent consultants? We scouted around for insights amongst holders of the ACRP Project Manager (ACRP-PM®) specialty certification, and here’s the feedback we received from a few of them about the paths they followed into project management and what they really do in their day-to-day jobs.
Setting us on the right track are ARCP Fellows Suzanne M. Kincaid, CCRA, ACRP-PM, FACRP, Owner and Principal Consultant of Responsibility Research Consulting, LLC, based in Nashville, Tenn., and Beth Bieze, MA, CCRA, ACRP-PM, FACRP, Clinical Quality Management Director for ProTrials Research Inc., a full-service CRO based in Los Gatos, Calif. For other perspectives and resources on this topic, please visit the ACRP Project Management Resource Center.
Q: What would your “elevator speech” be for describing what a project manager does in the context of clinical research?
Suzanne: I liken the project manager to the orchestra conductor. There are so many deliverables, moving pieces, team members, and interdependencies in clinical research. Without the orchestra conductor, everyone is just honking on their instruments, but it doesn’t make a song.
Beth: A clinical research project manager acts as the conductor of the trial, ensuring every moving piece works together toward a cohesive result. Their role covers overall study oversight, which includes protocol adherence, vendor management, budget tracking, risk mitigation, resource management, and more. Project management can look different depending on the trial’s design, phase, and complexity. Day to day, that means coordinating across departments and personalities, staying flexible as problems arise or requirements change, and keeping every task on track for both timeline and budget.
Q: What were you doing before turning to project management, and was it within the clinical research field?
Suzanne: I started at a site as a regulatory coordinator filing documents, then became a study coordinator. I naturally gravitated toward project management because the skills needed to be a project manager are the same skills that make a good study coordinator: planning timelines, maintaining good communication, influencing without authority, working with cross-functional teams, and adjusting to different individuals’ work styles.
Beth: I started as a clinical trial assistant at a local CRO. I gradually “pushed” to be included in team and sponsor meetings so I could learn more about the industry I was now working in. From there, I advanced to a clinical research associate (CRA) then lead CRA position. When I came to ProTrials, I became a project manager. Project management uses all the skills I accumulated in my other research positions and more.
Q: Did you experience a “lightbulb” moment in your career about suddenly deciding to become a project manager, or did it happen more gradually?
Suzanne: As a study coordinator, you see some well-written protocols and some poorly written ones. I have always been interested in efficiencies. The longer I was in clinical research, the more curious I got about how everything worked, how certain things ended up in the protocol. I wanted to see behind the curtain to understand how a final protocol ended up at a site and how everything worked.
Beth: It happened gradually. Working through the other roles that I mentioned gave me the confidence to work in the project manager position. I knew I could “manage,” but I needed to make sure I understood all the pieces I would be managing first.
Q: What skills from other specialties in clinical research have you found to be most transferable and/or most important to transfer to your activities as a project manager?
Suzanne: My experience as a study coordinator has been the most useful skill in project management: picturing first-hand how a protocol will be carried out at a site, what the participant experience will be, how the site staff will logistically carry out the schedule of events. I have carried the site and participant perspective with me all this time. Sites are the heart of clinical trials, and we need to see our study through their eyes and do what we can to make things easier for them. Understanding the procedures and workflow of the functional areas within scope of your project can help you understand roadblocks and rate limiting factors, and determine whether you have a process problem or a performance problem on your team. I was a clinical person, but I needed to understand more about data management, medical writing, laboratory analysis, and other areas outside my comfort zone so I could offer the most useful support to my projects.
Beth: Time management is definitely one. In any of the positions time management is important, but it’s key in project management. Having good organization skills, flexibility, a collaborative attitude, and a willingness to take on new challenges all come from my previous positions and transfer to my role as a project manager.
Q: What made you decide to seek out certification with the ACRP-PM® designation and how has it impacted your career?
Suzanne: I had been a project manager for many years and wanted to be recognized. I had investigated formal Project Management Professional certification [offered by the Project Management Institute] and spoken to certified project managers, but much of that didn’t seem applicable to clinical research. I also had the benefit of formal project management training from AstraZeneca during my career there. I decided to sit for the ACRP-PM® exam as soon as it was available to see how I would fare, having no expectations. I passed the first time, and was proud to advertise my project management knowledge with new credentials.
Beth: I was on the committee that helped write the first ACRP-PM® exam. Because of all our work and review of the exam questions, those on the committee were grandfathered in. I feel the ACRP-PM® designation along with my Certified CRA (CCRA®) designation gives credibility to my work and shows my commitment to clinical research.
Q: In your project management duties in clinical research, what has been your most challenging and/or most rewarding project to date?
Suzanne: The most challenging projects are those where there is a culture of siloed functional areas and everyone is out for themselves. Breaking that down and building a high-performing team of people working toward the same goal mid-project is a daunting task that takes a lot of patience and dedication. The most rewarding projects have been getting a new drug approved and seeing the ad on TV when you’re home at night with your family and saying, “I was a part of that!”
Beth: The most challenging part of projects can be all the coordination that has to be done. Depending on the size of the team, it can be difficult at times to get everyone together to discuss the study, its risks, and other impacting issues. The most rewarding thing is definitely seeing it all come together. Everyone working together toward a common goal and really getting it—understanding that the reason we work in clinical research is to help people. If a compound gets approved, that is even more rewarding.
Q: If advancement is someone’s goal, what seems to be the next most logical step up the career ladder for those with significant project management experience?
Suzanne: Project managers should really understand what they enjoy doing at work: Is it working with and developing people? Is it increasing their span of responsibility at a higher portfolio level? Is it corporate leadership? There are many avenues to pursue, but you should talk to people doing those roles to find out where those avenues lead and if that’s a direction you want to go. Promotions just for the sake of titles can lead to some long, unhappy days if you don’t enjoy the work you are doing. If you love what you do, it doesn’t seem so much like work.
Beth: First, you should let your manager know about your interests. There are many avenues to explore from a project management position. I personally have worked with training, business development, social media, quality assurance, and more. Next, explore what you think you might be interested in. Now you have the opportunity to grow your knowledge and hone your skills. Do something that interests you. It’s not always going to be the same thing for different people.
Edited by Gary Cramer
