Top 3 Skills For Clinical Trial Project Manager

Editor’s Note: This article is part of a series examining popular peer-reviewed articles from years past called “Peer-Reviews Revisited: Why You Should Read Today.” You can read the other articles in this series here.

Effective leadership is needed in a trial leader, but what exactly does that entail?

Consider: Phase III clinical trials involve hundreds of investigational sites and thousands of patients across different regions, cultures, healthcare systems, and regulatory environments.

What then are the 3 most important interpersonal characteristics (soft skills) of a successful project leader to ensure that all contributors to the clinical trial production chain work properly on time, within expected scope, and on budget?

This is not a casual question. One of the major obstacles in Phase III clinical trials still appears to be missing effective leadership at the project level, which is crucial in today's biopharmaceutical industry. Clinical programs have become increasingly complex given strong competition for productive sites; cost and time constraints; challenging internal and external environments; and large multinational stakeholder teams not to mention the nature of the biopharmaceuticals themselves.

The authors of this peer-reviewed article addressed the question of what skill sets a project leader/manager should possess to insure effective leadership and success to the clinical research professionals attending the regional chapter meetings, organized by the German Society of Pharmaceutical Medicine (DGPharMed) in Mannheim, Hamburg, and Berlin between February and September 2011. The survey results are presented and discussed in the article published in the January 2013 issue of Applied Clinical Trials.

Effective communication appeared to be the key, (number 1) soft skill of a successful/ideal project leader far ahead of clear goals (2) and a proactive working style (3rd).

The conclusion mirrored the personal perception of the 226 clinical research professionals representing predominantly CRO and pharmaceutical companies who work as project managers/clinical trial managers or are interested in this role.

Interestingly, long-term experience in clinical research and overall knowledge of drug development appear, however, to be less important for a project leader as compared to other knowledge, behavior, and skills.