People who are entering the clinical research profession can come from many other fields and with very diverse backgrounds. No matter their role, everyone acknowledges project management as an essential and invaluable skill set. Project management requires leadership, communication, and management skills that can be applied in any role across clinical research.
“Project management skills can make the difference between thriving in a role and just trying to survive while putting out fires,” says Beth Bieze, MA, CCRA, ACRP-PM, FACRP, Clinical Quality Management Director at ProTrials Research, Inc. “In fact, many clinical research professionals may already be doing project management tasks without necessarily realizing it.”
Bieze explains that effective leadership in project management requires core competencies such as emotional intelligence, which involves self-awareness and being able to respond thoughtfully to the emotions of others. Other key competencies include attracting and retaining diverse talent; promoting social and ethical responsibility; adapting readily to change and emerging technology; empowering team members and fostering collaboration; using critical thinking; challenging the status quo; and encouraging learning and growth.
Effective communication is also a critical element of project management. Bieze notes that “seven Cs” are useful reminders to ensure that communication is:
- Complete: Providing all necessary information for clear understanding and informed decisions
- Concise: Conveying a message with brevity, without unnecessary details or information
- Clear: Ensuring the message is easily understood without ambiguity or confusion
- Concrete: Using specific facts and evidence for credibility
- Considerate and believable: Understanding audience needs and tailoring messages for empathy and relevance
- Correct: With accuracy in grammar, spelling, punctuation, and factual information presented
- Courteous: Showing respect, politeness, and professionalism in interactions with others
“Understanding various leadership types is helpful, both in management of teams and in recognizing the styles used by senior executives,” states Jennifer McLeland, PhD, RPSGT, CCRC, ACRP-PM, FACRP, Manager of the Division of Clinical Research at Washington University School of Medicine. “Dynamic managers can better manage their direct reports and also gain an advantage from the ability to understand the perspective of their own leaders.”
Workshop—Project Management Basics for Clinical Research
Join Beth and Jennifer at ACRP 2025 [April 24-27; New Orleans, La.], where they will help attendees develop their leadership, communication, and management skills to effectively manage projects and lead teams. View complete schedule.
“Project management skills can bring career benefits by enabling individuals to effectively oversee projects and navigate challenges using a well-developed personal arsenal of competencies,” notes McLeland. “These versatile skills, which can be enhanced through self-assessments, training programs, and virtual toolkits, are applicable to clinical trials across all therapeutic areas.”
Further, as professionals continue to refine their project management skills, artificial intelligence (AI) is becoming an increasingly influential tool in clinical research, notes Bieze. “Chatbots like ChatGPT are now being used for tasks such as drafting bid proposals,” she says. “However, the quality of their output is only as good as the information they are provided, making careful review essential. While security challenges similar to those in other industries remain, generative AI and large language models are ultimately expected to drive significant improvements in study efficiency.”
Edited by Jill Dawson
