1. Global Supply Chain Management
2. Project Leadership: Getting It Right
3. INC Research Discusses How CROs Can Help Oncology Trials
Clinical development programs in the biopharmaceutical industry have become increasingly complex and continue to do so. In
view of strong competition for productive sites; cost and time constraints; challenging internal and external environments;
and large multinational stakeholder teams, the skill set of a clinical project leader is nowadays a key success factor. Executive
clinical project leaders are involved in development programs encompassing a range of highly complex clinical trials. The
key operational challenge of these programs are Phase III clinical trials involving hundreds of investigational sites and
thousands of patients across different regions, cultures, healthcare systems, and regulatory environments. How can it be ensured
that all contributors to the clinical trial production chain work properly on time, within expected scope, and on budget?
One of the major obstacles still appears to be missing effective leadership at the project level.1
What are the three most important interpersonal characteristics (soft skills) of a successful/ideal project leader? The authors
addressed this question 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 this article.
The survey was conducted among the clinical research professionals who attended the regional DGPharMed workshops entitled
Project Management in Clinical Research held in Germany in 2011. The attendees heard about the principles of project management
as applied to the conduct of clinical trials. The vast majority of participants then took part in the survey and selected
the three most important characteristics of a successful/ideal project leader and rated these characteristics as most, second,
and third most important. The meaning of the term project leader was explained to the respondents as a clinical project manager,
study manager, or similarly named function with the responsibility to manage and primarily lead the clinical trial, project,
or program depending on the size of the organization and the applicable settings. A skill set differentiation between clinical
project leadership and clinical project management was not conveyed.
The multiple-choice questionnaire offered the following pre-defined characteristics without further definition of terms: long-term
experience in clinical research, risk awareness, medical expertise, knowledge of drug development, innovative, confidence-building,
dependability, effective communication, clear goals, and proactive working style. The authors pre-selected these characteristics
based on results of a Drug Information Association (DIA) tutorial attended by Schenk—prior to the DIA Conference entitled
The Future of Pharmaceutical Project Management, Weston, Florida, November 13-14, 2007—where the participants (N=15) identified
the three most important personal characteristics of an ideal project leader without any pre-defined answers.
In the 2011 survey, a free text option allowed for the addition of further characteristics. To rule out any influence by the
order of pre-defined answers, the last workshop (23% of participants) utilized the questionnaires with a changed sequence
of the characteristics displayed in the questionnaire forms. The order of options on that finally used form was selected on
a random basis.