Nowadays more and more industries are moving to a "management by objectives" way of business. This is especially true for
the pharmaceutical industry in general and clinical trial management in particular.
Most clinical trials are operated by trial teams with specific team objectives. The number of project manager positions is
exponentially growing as is the number of project management courses. Despite this, leadership in large clinical projects
still appears to be a major obstacle.
Without the objective of writing yet another course, this article reviews the key requirements for good clinical project leaders,
focusing on potential issues that can lead to project failure if not properly addressed. It is based on the project leadership
requirements proposed in a workshop co-moderated by the authors at the 2005 Applied Clinical Trials European Summit in Paris.
Proposition I: A project leader requires exceptional organizational skills
Figure 1
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The development of new drugs is a highly specialized business, requiring in-depth knowledge of many clinical, biological,
pharmacological, and chemical parameters. The pharmaceutical industry is one of the most highly regulated industries, with
many specific and detailed requirements for processes. This makes a successful clinical trial performance by definition a
complex effort requiring input from many specialties (see Figure 1).
Therefore, many pharmaceutical companies and Contract Research Organizations (CROs) have implemented a matrix project management
structure to optimize the performance of clinical project teams. The most crucial role within this team is assumed by the
project leader, who is responsible for the entire project, which starts in the trial planning phase and lasts until completion
of the study report or manuscript for publication. Thus, highly developed organizational skills are a key prerequisite for
effective project management.
Especially in the early project phases, the main emphasis has to go into meticulous planning and preparation. An almost limitless
list of items needs to be addressed to ensure that all requirements are met, including:
- project sponsor requirements/expectations
- scope of project, countries involved
- timelines and milestones
- internal project resourcing, training of team members
- third-party providers
- eClinical tools
- budget
- applicable regulations and ethical aspects
- finalization of study protocol, CRF, patient diaries
- investigational product availability.
Addressing these needs requires proper planning and documentation to ensure that the project sponsor and all project team
members have the same understanding of directions, tasks, and requirements.
In order to be successful, the Project Management Plan is made up of elaborate plans for statistical analysis, pharmacovigilance,
monitoring, project quality management, project communication, etc. Although the majority of plans are usually prepared across
most clinical trials, one vital piece is not always present: a risk management plan.
What to do if the trial progress deviates from the plan? What to do when recruitment is slower than forecasted, tolerability
less favorable than expected, interim analyses show other results than assumed? A seasoned project leader is prepared for
these challenges and manages to redirect its project and the multidisciplinary team according to the new insight.
Proposition II: Effective project leaders care about individuals and their culture
Usually, the technical aspects of project management are rather well taken care of, together with the scientific knowledge
that is required. One important element that is frequently ignored, however, is whether the project manager has the right
skills to deal with the soft skills of leadership: managing people and dealing with the human and cultural aspects.
