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International Clinical Trials

Leading Edge

One of the most popular questions asked in business – including the pharmaceutical arena – is ‘what are the qualities of a good leader?’ This used to be asked frequently in project management and clinical trials circles, until the software wave overwhelmed the profession. However, the failure of software to create successful clinical project managers or clinical trial leaders means the human component is returning – and this question continues to be posed.

Ensuring that personnel, particularly those in emerging markets, have the critical thinking skills they need to successfully conduct local and global clinical trials is a difficult operational challenge. Providing good clinical practice training is relatively simple; nurturing future clinical trial leaders is far more complex.

This article suggests how to apply one of the critical thinking skills required, the art of managing involvement – a leadership skill that has not been previously applied within the life sciences industry.

Effective Leaders

What is there in common in the make-up of effective leaders such as civil rights activist Martin Luther King, statesman Colin Powell or football coach Vince Lombardi, for example? The pursuit of some common style among this diverse array of people would be futile. They have employed different approaches, possessed different strengths, appealed to different groups. In fact, the worst place in which to look when seeking a successful approach to leadership is in the personality of a successful leader.

This is especially relevant in organisations that require more and more employees to take on project management roles, such as those in the clinical research sector. The presence of visible ‘leadership traits’ wanes as organisations sink deeper into their talent pools for project managers. Organisations then find themselves in the position of having to develop leaders from within their ranks.

There are three premises that organisations and project managers in the pharma industry must address as they develop leadership both within their ranks and within themselves:
  • No one style of leadership is appropriate in every instance. Each project and management situation has variables which will determine the optimum behaviour
  • Leaders are under tremendous time pressures and are constantly struggling with the choice between being time-efficient in dealing with a particular situation, or making a time investment that may help to develop the capabilities of others on the project team
  • No leader can succeed by employing a style which demands talents that they do not possess. Conversely, some project resources will not respond to certain leadership styles, no matter how talented the project manager is at employing them
Under these ever-present scenarios, how does a project manager increase their leadership effectiveness? To what extent is it necessary to adapt your style in certain situations? How do you know which style of leadership behaviour will be correct in a given situation? Research carried out by Critical Skills Inc over 457 global trials (mostly focused on USA and Asia) indicates that there is a defined range of five leadership behaviours – from autocratic to consultative – available to a project manager in any given situation. Misapplication of these behaviours is often what reduces their effectiveness.

Resolve Alone
The project manager resolves a situation alone, without the participation of anyone else, or develops a recommendation without involving others. There is no opportunity for others to influence the resolution or recommendation. Example: the project manager privately draws up a work schedule and gives each team member a copy.

Ask Individuals
The project manager obtains information from one or more other people one at a time, before resolving a situation. The project manager need not inform the other(s) about the issue of concern. There is limited opportunity for others to influence the resolution or recommendation. Example: a project manager asks each team member individually about his or her current workload, then draws up a work schedule.

Consult Individuals
The project manager discusses a situation with one or more other people individually, getting their ideas and suggestions, before resolving the issue. There is some opportunity for others to influence the resolution or recommendation, although the project manager’s decision need not necessarily reflect their input. Example: a project manager meets individually with team members to discuss how they think work should be scheduled, then draws up a work schedule.

Consult Group
The project manager discusses a situation with other people in a group meeting, obtaining their ideas and suggestions, prior to resolving the issue or developing a recommendation. There is significant opportunity for others to influence the resolution or recommendation. However, the project manager makes the final decision, which need not reflect others’ input. Example: a project manager calls the team members together as a group to discuss how work should be scheduled, then draws up a work schedule after the meeting.

Resolve as a Group
The project manager discusses a situation with other team members as a group and the group works together to develop a resolution or recommendation. The project manager may chair the meeting, establish boundaries for an acceptable outcome, and provide information and ideas.

Each member of the group can have a significant impact on the resolution or recommendation. The project manager agrees to accept and implement any conclusion reached by the group. Example: a project manager meets with the team members as a group and the group works together to develop a schedule during the meeting.


Most project managers tend to stick with one or two styles based on their personal preferences and therefore miss out on opportunities to better guarantee the implementation of their plans. However, the research indicates that leadership effectiveness is enhanced significantly when project managers apply the appropriate behaviour at the appropriate time.

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Eric Morfin is a Partner with Critical Skills Inc and the Clinical Excellence Research Institute, and has over 27 years of leadership and managerial experience in the life sciences industry. He has led many departments, such as project management, QA/QC, data management, operations and clinical trials, for many leading pharma companies worldwide. Eric also founded the non-for-profit, which is dedicated to enhancing the skills and knowledge of project professionals in the pharma, medical devices and healthcare industries.
Eric Morfin
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