Project management principles can help ensure the success of work at all scales from strategic organizational initiatives to day-to-day tasks. Workflow and productivity can be optimized using a variety of project management tools. This enables clinical research professionals to manage multiple active studies simultaneously, despite challenges such as competing demands, shared staff, and overlapping timelines.
“There’s a stigma associated with project management—including the perception that it involves a large amount of extra work,” according to Leslie Pimentel Byatt, MSML, MBA, CCRC, PMP, FACRP, Director, Clinical Trials Operations, at the University of New Mexico Hospital. “While it’s true that there is extra work the first time project management techniques are applied, in clinical research many projects are template-driven. Once developed, these templates can be used repeatedly.”
There are three major steps for sites wishing to use project management techniques to take a proactive approach to planning:
- Break it down: Using advanced project management methodologies such as a work breakdown structure (WBS) to divide up complex site operations to enable management of multiple concurrent studies with competing resources.
- Map it out: Analyzing and optimizing project schedules using Gantt charts, dependency mapping, and critical path analysis to proactively identify bottlenecks and mitigate risks.
- Scale it down: Integrating strategic project management frameworks with operational task management to create scalable systems that assign daily priorities with organizational objectives.
A key element of project management is creation of a work breakdown structure to transform projects into manageable components. For example, components to activate a new oncology trial might include feasibility, budgeting, contracts, regulatory elements, site preparation, site training, patient identification and enrollment, and study closure.
Time Flies: Project Management from Strategic Initiatives to Daily Tasks
Join Leslie at ACRP 2026 [April 24-27; Orlando, Fla.] as she guides participants through applying proven project management principles across all scales of work, from organizational initiatives to everyday task management. View complete schedule.
“I’d describe a WBS as a thinking tool,” explains Byatt. “Different stakeholders might look at a project in different ways. A project management specialist would apply tools in a structured manner, but many people would simply create an informal outline, mind map, or series of Post-It notes to capture the main elements. WBS works by making hidden work visible, revealing dependencies, and informing realistic planning.
“Project management has become an essential skill for clinical researchers over the past few years,” says Byatt. “Its importance is now acknowledged, and failing to embrace project management in some way is likely to put clinical research professionals at a disadvantage. Once these skills have been learned for large-scale initiatives, project management can also transform daily task management, reducing stress and increasing efficiency.”
Edited by Jill Dawson
