In an ideal world, clinical trial teams would have all the proper resources of time, personnel, and funds necessary for delivering a successful project on time and in scope, every time. Guess what? We don’t live in an ideal world. That’s where project management specialists like Eric Morfin, founder and managing partner of Critical Skills, Inc., come in.
Leading a sold-out, full-day, pre-conference “Clinical Project Management Excellence and Best Practices” workshop for ACRP 2019 in Nashville today (April 12), Morfin called project managers—whether serving on staff or as consultants—the cornerstone for being realistic and forthcoming to the full trial team about matters of capacity, scheduling, budgets, and more.
“I’m not suggesting it’s easy to implement” the tenets of good project management, Morfin said, but in his nearly 25 years in the role, he has learned to be a trainer and mentor in cases where the people assigned to projects do not necessarily have the skills or background for the work at hand. He has also learned to overcome organizational resistance to change when he finds process-based roadblocks to a project’s desired outcomes.
ACRP Project Manager (ACRP-PM®) Subspecialty Designation
The ACRP-PM® credential was created in direct response to growing demand for validation of clinical research-specific project management competency. ACRP-PM formally recognizes clinical research professionals who currently hold an ACRP Certification and have demonstrated knowledge in clinical research project management by passing a 60-question exam.
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Based on his experience, Morfin said that “only in 7% of cases is the root cause for the resistance to change found in an individual.” In the remaining 90+% of cases, the resistance comes from “the environment” in which the project is being conducted. “In most of the individual cases, you can change behavior” for the better, but in rare cases, “you need to replace the individual,” he added.
As he walked his workshop attendees through a variety of case studies showcasing real-world project management challenges, Morfin also highlighted what he called the “4 Skills for Successful Management in Life Sciences Projects”:
- Scientific and Research & Development Process Knowledge
- Technical Project Management
- Risk Analysis, Root Cause Analysis, and Decision Making
- People Skills and Leadership
Again, in an ideal world, project management plans should always include some time at the project’s closure for the clinical trial team members to reflect on the “lessons learned” throughout the experience, Morfin said. “We are always so busy” getting to the next project that sometimes “we forget to close the previous one” properly, he noted.
Author: Gary Cramer
