We Are All Project Managers, But We Need Help
By Dan Schell, Chief Editor, Clinical Leader
“I'm about to blow your mind, because everybody in clinical research is a project manager,” says Jess Thompson, MS, MBA, PMP, who is an industry consultant and also the founder and CEO of the Clinical Research Project Management Association (CRPM). Sure, that sounds exactly like what someone who is the head of a project managers association would say, but she made some really compelling arguments during our interview that I’m guessing many of our readers would agree with. But before we get into that, let’s first discuss why I even chose to interview Thompson.
If you read my article What's The Deal With eConsent?, you may remember Thompson spoke at length about her — mostly negative — experiences with that tech. Before that, I watched her take part in a panel about site tech at the Save Our Sites conference where she and other panelists wore powdered wigs like a bunch of UK barristers (you can see a photo here). In recent years, she’s emerged as a strong voice in the industry, not only on platforms like LinkedIn, but at various industry conferences. And although she heads up CRPM, she admits that her evolution from CTM to project manager was “accidental” — and she guesses it was that way for many of today’s PMs.
NO MORE FLY-BY-THE-SEAT-OF-YOUR-PANTS TRAINING
“Many of us act as project managers in clinical research, but it's not acknowledged as an actual role,” Thompson says. “In our industry, you learn from the person above you. But if they weren’t trained correctly, we’re just doing fly-by-the-seat-of-your-pants project management when there are tools and methodologies that can make everybody's life so much easier.”
Thompson has a project management professional certification from the Project Management Institute (PMI), but she insists that’s not enough to become a PM in clinical research. Sure, you can apply some of the basic PM methodologies to a role in clinical research, but you also need a strong understanding of how the industry’s ecosystem works including everything from site operations to regulations. As such, she is currently working to get her clinical research-specific training approved by PMI to have CRPM be listed as an authorized PMI training partner. “In clinical research, our projects are insanely complex,” she says. “Say you have a Phase 3 trial that is being conducted in three countries with 250 sites and 40,000 patients. There’s a sponsor, a CRO, and sites involved. I did the math; that means there’s over 1,500 individuals performing project-management activities.”
CAN WE LESSEN THE AMOUNT OF “FIREFIGHTING?”
Make no mistake; as a PM, you’re a firefighter. You always being reactive and solving one problem or completing one part of the puzzle while multiple others await your attention. Think some type of technology or AI is going to solve your problems? Think again, says Thompson. Only experience is going to really make a dent in common PM struggles like building manageable timelines or realistic budgets.
And this job isn’t getting any easier as more and more sponsors and CROs tout their “lean” approaches, which, she says, usually means cutting staff, not the true definition of getting rid of redundancy and heavy processes and policies. “The misuse of that word is really messing up our industry. They're giving us timelines that aren't operational. They're presenting unrealistic budgets and wanting us to maintain the quality with fewer resources. That goes against everything in project management.”
MENTORING ON MENTAL HEALTH
There’s a common industry stat that gnaws away at Thompson and simultaneously drives her project management mission: 90% of clinical drug development fails. She also admits that better project management isn’t the silver bullet to this longstanding problem — but it sure could lead to lowering that percentage that haunts her.
Unfortunately, time is the key element of many of her suggestions for improving clinical trials, but time is in short supply in this industry. For example, she advocates taking more time for planning, benchmarking, and reviewing lessons learned.
“I always say there are some basic skills every clinical research professional — no matter what their role — can benefit from: e.g., risk management, iron triangle [quality, time, budget], communication pathways, stakeholder analysis and management. That’s the kind of training I have traditionally given away for free from CRPM. But we also have deeper dive, paid courses that go more in depth on one specific topic. Really, the paid option just gives members more of my time; it’s almost like coaching.”
She has plans to offer a twice monthly CRPM PRO chat where members can talk with Thompson and other members about hot topics in their field in a sort of mentoring-like environment. One of those topics, inevitably, will be related to the mental health of these clinical professionals. In fact, she says that comes up a lot in discussions with members. Afterall, burnout and anxiety are both rampant in this industry, especially among CRCs, CTMs, and PMs.
Thompson has always been very vocal about her own mental health struggles that were rooted in her clinical research career. “I would work until a job was done; I was a workhorse,” she says. “You could always count on me, but I always put everything else in front of myself, and working crazy hours and being a perfectionist took a toll on me.” In 2022, due to extreme anxiety, she checked herself into a partial hospitalization program, which she says, “saved my life.” Months later, she created a LinkedIN post about her experience and why she had made this choice. Overnight, she estimates the post received about a million views, and in the morning her inbox was filled with hundreds of messages from people in the clinical research community who had similar struggles.
“I caught a lot of backlash for the first time I posted about my anxiety,” she says. “But I knew that if I was struggling, other people in my profession were, too. And if I can help one person feel better or feel not alone, then that's worth me taking this risk of putting myself and my struggles out there.”