Clinical Trial Managers Grapple with Complex Expectations

Dalfoni Banerjee, Principal Consultant and CEO, 3Sixty Pharma Solutions

Firefighters and other first responders are a critical component of a town’s safety infrastructure. When life and property are threatened, it is these brave professionals who meet the current crisis head on. At the other end of the spectrum, visionaries and builders are also a key foundation of a town. Developers of new structures provide the building blocks for expansion.

Guess which category most clinical trial managers are forced into? “They are usually super-busy, primarily in the weeds—and often-times consumed by tactical challenges [such as] problems with specific site initiations, database issues, other study logistics,” says Dalfoni Banerjee, principal consultant and CEO of 3Sixty Pharma Solutions. In other words, most of these managers spend their days “putting out fires” without time to “consider work from a birds-eye view,” she adds.

Part of the problem is the perceived skillset required of clinical trial managers. “Whereas scientific acumen is usually a prerequisite for the role, strategic thinking and other soft skills are not prerequisites,” Banerjee says.

That’s a problem because it keeps the manager locked into the near-term firefighter role. With balanced skills and priorities, a clinical trial manager “is a problem-solver, but, just as importantly, a problem-anticipator/risk-identifier and mitigator,” Banerjee says.

To help clinical trial managers transform into builders rather than just firefighters, Banerjee advocates a seven-prong approach:

  1. Plan, Organize, Prioritize, and Establish Metrics
  2. Infuse Customer Focus
  3. Innovate
  4. Remain Goal-Focused
  5. Communicate with Savviness
  6. E-mail Like a Pro
  7. Plan for the Unexpected

7 Breakthrough Behaviors for Clinical Research Project Managers

Join us at ACRP 2019 in Nashville this April to explore the 7 behaviors critical for successful clinical project management. Dalfoni Banerjee will discuss these behaviors in depth while providing real-world examples and tried-and-true techniques that will help you avoid common pitfalls.

View Session Details >>

ACRP 2019


“The key to remaining goal-focused is defining, tracking, measuring, and re-evaluating throughout the project,” Banerjee says. Soft skills are a vital component of any successful project, she adds: “I often remind clients that even when they are doing a stellar job, if they aren’t communicating with key stakeholders in ways that resonate with them, all their excellent work and successes are almost for naught.”

Author: Michael Causey