If all the anecdotal evidence about how many clinical research professionals “fall into” their first role in the field without exactly meaning to and find themselves in “sink or swim” conditions can be taken at face value, perhaps some comfort can be gained from knowing that progression into later roles is more often achieved at a deliberate and rewarding pace. Given enough time and exposure to multiple other areas of specialization in the clinical trials environment, many professionals who wish to continue working in the research arena, but who also desire a change of pace with new responsibilities, turn to project management.
Joining us in this Q&A to share insights and experiences from their career paths are five professionals who hold the ACRP-certified Project Manager (ACRP-PM®) designation:
Courtney Alexander, CCRC, ACRP-PM, who works remotely based in Alabama as a Project Manager for Centricity Research.
Ysmil Contreras, MD, CCRC, ACRP-CP, ACRP-PM, Associate Director of Clinical Operations for ICON plc.
Lisa Ince, CCRC, CCRA, ACRP-PM, FACRP, a Project Manager for Syneos Health.
Jennifer McLeland, PhD, RPSGT, CCRC, ACRP-PM, FACRP, a Manager in the Division of Clinical Research at Washington University School of Medicine in St. Louis, Mo. She will co-lead an ACRP 2025 Workshop on “Project Management Basics for Clinical Research” next April in New Orleans along with Beth Bieze, CCRC, ACRP-PM, FACRP.
Nikki Skirvin, CCRC, ACRP-PM, who works remotely based in Tennessee as a Senior Project Manager for a contract research organization (CRO).
ACRP: What were you doing before turning to project management, and was it within the clinical research field?
Contreras: I was a clinical research director with more than 20 years of broad experience encompassing different functional areas, including clinical, operational, regulatory, budget, compliance, site management, data management, and supplies in Phases I–IV of clinical trials development.
Ince: I have been in the industry for 20 years. I started as a clinical research coordinator (CRC) working directly with patients. I moved into the clinical research associate (CRA) role and then was a clinical trial manager (CTM) where I was managing and partnering with sites. About three years ago, I took the leap to the project management role, where I focus on the financial health of studies.
McLeland: I started off working in clinical research as a graduate student and have been working in various clinical research roles for more than 22 years. Just before transitioning into a project management role, I had the job title of Senior CRC.
Skirvin: I spent more than 10 years at the site level, starting as a CRC and working my way up to site management. From there, I transitioned to the remote work environment where I have spent the last four years working at the CRO level. That led me to my current role as a Senior Project Manager.
ACRP: Did you experience a “lightbulb” moment in your career about suddenly deciding to become a project manager, or did it happen more gradually?
Alexander: For me, the transition was gradual. I have worked as a coordinator and site operations manager for more than seven years. I am constantly looking at financials, study metrics, and such and trying to determine the best ways to reach the company’s goals. Identifying those goals as their own type of “project” aided in working down the details for the necessary elements, impacts, and focus points for project success. It was then I realized that I found enjoyment in identifying needs and process improvements, and in working with teams to find the best outcome.
Contreras: Becoming a project manager happened more gradually because, with my prior experience and coming from my perspective, this was the correct path. This path, including certification, would formally validate and enhance my skills to manage resources, processes, and project priorities in the clinical research field. I believe these core skills are necessary to successfully complete any project.
Ince: I always knew where I wanted to move within my career and felt that being a strong project manager comes from an overall expertise of all facets of the study—from the site perspective to the CRO/client perspective. I wanted to gain that knowledge step by step, but was always moving in the direction to manage clinical trials. I had a high level of expertise on the clinical side, but knew that I needed to strengthen my financial side, which is what led me to project management.
McLeland: I gravitated toward taking on project management tasks while working as a CRC, so it was a natural career progression. I had a “lightbulb” moment while reviewing my annual study coordinator job description, realizing that a multitude of the new tasks that I had taken on fell under that generic category of “other duties,” and no longer fit the traditional duties of a research coordinator. At that point, I knew that there must be a different job title that was in better alignment with my job duties.
Skirvin: I wouldn’t say there was a lightbulb moment, but once I started in clinical research more than 17 years ago, I knew I’d found the perfect field for me. It is a matter of constantly adapting to challenges and you are part of something so much bigger than yourself—hope.
ACRP: 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?
Contreras: In my opinion, aside from learning specific regulations, all applicable regulatory guidelines, and/or policies, some of the transferable skills to become a project manager are the ability to communicate, plan, multitask, prioritize, mitigate challenges, understand work impact or risks, resource optimization, adaptability, teamwork, critical thinking, and client relationship management.
Ince: I believe that moving through the clinical process within each role has given me the most comprehensive understanding of how to successfully manage a study. Knowing the site’s perspective allows me to make better decisions regarding how studies are run at the site level. I am better able to assist my CRAs/CTMs in partnering with sites to address challenges and provide immediate solutions. I am able to assess where additional costs may be needed more proactively by understanding how the site will run the study and how best to monitor the sites.
McLeland: The analytical skills that I learned while working as a CRC have served me well in project management. As I gained more experience as a study coordinator, I learned to understand each problem and to seek out answers myself, rather than immediately asking my manager or principal investigator. Critical thinking and problem solving elevated my performance as a study coordinator. Thinking through problems, considering available options, and making well-informed decisions have been essential skills for success in project management.
Skirvin: Communication skills, time management, delegation, proactiveness, organization, and adaptability.
ACRP: What made you decide to seek out certification with the ACRP-PM designation and how has it impacted your career?
Contreras: Clinical research is a highly regulated field, and the facts that this designation is the only one specific to clinical research and is widely recognized allowed me to seek a designation that fits well with all the requirements. I believe this credential is very valuable because it enhances my professional development and will continue to be valuable as I may move through different jobs or roles in the future.
This designation has impacted my career in many ways, including growing my knowledge and skills, establishing professional credibility, demonstrating a commitment to ongoing learning and professional development, upholding industry standards, and allowing me to manage all aspects of my work more effectively.
Ince: I am a huge advocate of certification. I also have CCRC and CCRA certifications which, I believe, represent my commitment to my career and the commitment I have had at each step along the way. I feel proud to show the knowledge I have gained and want to show my colleagues and clients the depth of my understanding by gaining and maintaining my certifications. I also feel that it positively impacts the perception clients have of my expertise.
McLeland: The opportunity to assess my knowledge and skills in clinical research project management motivated me to take the ACRP-PM exam. I felt like I had a solid amount of experience and knowledge in project management, but wanted to see how I would do on an exam that specifically tested for those skills and abilities. It felt validating to know that there was a name to assign to what I was doing at work and a way to quantify my skill level.
In my experience, a good amount of project management has been approaching challenges, using critical thinking, evaluating options, and making sound decisions. No two days are ever the same, and I enjoy that about project management. Earning the ACRP-PM credential validated my ability to be a project manager. I think that it gave me more confidence in myself. It has also been a way for me to demonstrate to my employer and grant funding agencies that I have the necessary skills of a project manager.
Skirvin: I’ve been certified as a coordinator with ACRP for more than a decade. When the ACRP-PM designation became available, I knew I had to take it. ACRP’s exam eligibility criteria and exam content are extremely robust. Without having significant experience in the role and a solid knowledge base, you will not pass these exams. Gaining the ACRP-PM designation meant to me that I had both of those things. I’ve had incredible opportunities in my career, and every one of them started after I achieved my CCRC certification and have continued with the ACRP-PM designation.
ACRP: In your project management duties in clinical research, what has been your most challenging and/or most rewarding project to date?
Ince: This would be on the same project. My primary project manager role is a dual role that is new for my company; I am a CTM/Project Manager, which means I am the lead for both the clinical and financial aspects of the study. I love working on the clinical side, as that is where I grew up in the industry, so it is very rewarding to be able to continue to lead my clinical team. I am also still learning the financial side of research, which has been a challenge but a great learning experience. I feel I am getting more versed in how to utilize all of my strengths to ensure both clinical and financial study health.
McLeland: My most rewarding AND challenging project to date has been working on the North American Prodromal Synucleinopathy (NAPS) Consortium for REM Sleep Behavior Disorder. In the original grant, I had the opportunity to function as the primary study coordinator at our site and in a project management role for the entire consortium. When we began Phase II of the study in 2021, I moved into the role of Deputy Director for the consortium, and I continue to work on project management–related tasks along with three project managers at other academic sites.
Skirvin: My most rewarding clinical trial was a psoriasis study where I got to see multiple patients improve. One particular patient gave me the opportunity to see with my own eyes how much clinical research can change a patient’s life. This patient was a young man who had plaques all over his body. This led to him being very embarrassed to go out in public in anything besides long sleeves and long pants, even in the heat of summer. By the end of the trial, he achieved a huge improvement in the plaques. He even took a beach trip with his family where he proudly wore shorts and a T-shirt.
ACRP: If advancement is your goal, what seems to be the next most logical step up the career ladder for someone with significant project management experience?
Alexander: I think that the project manager’s scope covers multiple aspects, especially regarding the clinical trial industry. I find that project managers could easily have transferable skills for leader/director roles in multiple departments such as regulatory or legal to finance—each project manager likely brings his or her own skill level regarding different projects and the expertise they have, but organizational and process development skills, along with good interpersonal communication skills, are transferable industry-wide regardless of the site, sponsor, or CRO.
Contreras: From my perspective, if you are aiming for a role that allows for growth, to get certified as an ACRP-PM is the ideal approach. It affirms your skill set and enhances credibility from a formal, recognized, and reputable credentialing program in the clinical research industry.
Ince: This would really depend on the company, but typically the move from project management to a more global role would be expected. This would be more about project delivery versus project management; so, moving from managing individual studies to managing multiple studies or portfolios at a higher level would be expected. The move could also be a move from CRO to sponsor, or vice versa, depending on the required tasks. Moving into business development could also be a step up the career ladder.
McLeland: Much like the other roles in clinical research, the next most logical step depends on your education, experience, and interests. One of the phenomenal things about clinical research is that there are various directions you can take in your career. It’s up to each individual to determine what path is best in his or her career progression. I enjoy working in an academic setting and am devoted to a longitudinal, investigator-initiated study that I’ve been working on for years. My interest was and continues to be in challenging myself within my current academic institution and not looking to move outside my university. The natural progression in my case was to move from project management to a research management position, and then into a project management–type leadership position in the research consortium that I’ve worked with for years. However, this was my chosen pathway that is unique to me. I am excited to come to work each day and love what I do; that isn’t to say that this would be a dream job for everyone. For someone else, the next step after having significant project management experience could be a position as a senior project manager or a CRA. Personally, I’ve never sought out specific job titles. I’ve been fortunate enough to have the opportunity to challenge myself by taking on new tasks and transitioning into formalized roles and job titles that fit the job.
Skirvin: I think opportunities are limitless for someone who is a strong project manager because that skill set translates into so many other roles. I will say that, for me, it is continuing to learn and grow every day in the field of clinical research so that when the next step presents itself, I will be ready.
Edited by Gary Cramer
