Clinical Research: Phase 1 - Phase 4

The Top 4 Problems Facing Clinical Research Project Managers (And Their Solutions)

Dealing with difficult situations is part of the job for project managers in any field, but clinical project managers (CPMs) must overcome a number of unique obstacles on the way to successful study completion. Read on for some of the biggest issues facing project managers today, as well as a few practical strategies for resolving them.

1. Disorganized study programs

This may seem obvious, but proper organization is all too often overlooked. It ultimately falls on the project manager to make sure a clinical trial runs smoothly — and a good CPM is there to plan out everything that goes into it. Preferably that happens at the very beginning, but experts can also be brought in at later stages to tighten things up. Just keep in mind that it’s easier to start with a plan that works rather than to go back and fix systemic errors.

And those plans aren’t just the study protocols themselves. CPMs are also responsible for feasibility studies, risk reports and study timelines. Basically every discrete job that goes into a trial needs to be delegated to the right person, with all roles and processes well documented. Successful CPMs are proactive, carefully outlining everything that must be done while also deciding what happens when things don’t quite match up with that plan. All other aspects of project management essentially flow from this principle.

2. Research-naive sites

Everyone starts somewhere and study sites are no exception. Unfortunately, what makes for successful clinical practice doesn’t always translate perfectly into good clinical research practices. All sites may need to be educated at study start-up, but clinics new to research need extra attention. And that comes down to better — and smarter — research training. Teach the right way the first time, but also make sure to have a system in place to identify and address any deficits later on.

3. The clinical research talent shortage

With the number of trials on the rise, many organizations are seeing shortages of qualified research staff — especially clinical research associates — all over the industry. Even the best CPMs can’t field a winning team if they can’t find the right players. Understaffing leads to communication breakdowns and overwhelmed sites.

Keeping that in mind, employee retention and recruitment become top priorities for CPMs. An effective CPM takes team member satisfaction seriously, discouraging burnout by making sure individual needs are being met. Continuous professional networking is also crucial in finding potential new faces to fill in any gaps.

4. Lack of local infrastructure

With the push to include more traditionally underserved populations from inner cities and rural areas in clinical trials, it can be a struggle to ensure that a site — and its enrollees — have everything necessary for study success. However, even resource-rich sites aren’t exempt, with many encountering data collection woes. Project managers can solve these issues by working with local experts to identify problem areas and propose practical solutions.

What about you? Are you finding your study at any of these or any other roadblocks? Learn more about how we can help with our dedicated project management services.