spacer
home > ict > spring 2013 > leading edge
PUBLICATIONS
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.

Conclusion

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.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
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 BioPharmaPM.org, which is dedicated to enhancing the skills and knowledge of project professionals in the pharma, medical devices and healthcare industries.
spacer
Eric Morfin
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

MedPharm announce expansion of partnership with Palvella Therapeutics in developing a new treatment for the debilitating rare disease, pachyonychia congenita

MedPharm Ltd have announced the expansion of their partnership with Palvella Therapeutics, Inc., a Philadelphia-based biopharmaceutical company focused on developing and commercialising therapies for debilitating, rare genetic diseases. To date, MedPharm has employed its world-renowned specialist formulation expertise to support Palvella’s development of a novel, high-strength rapamycin topical formulation for application to the skin (PTX 022) as a disease-modifying treatment for pachyonychia congenita (PC). Most recently, MedPharm has made arrangements to manufacture the clinical (IMP) batches for use in Palvella’s upcoming Phase 2/3 clinical study.
More info >>

White Papers

Challenges of Analytical Method Transfer in the Pharmaceutical Industry

RSSL

The development and validation of suitable analytical methods is a critical part of the overall drug-development life-cycle. For the majority of products, particularly those that are clinically successful, the transfer of the analytical method between laboratories will be required. This process is designed to verify that a given laboratory is capable of performing a test method for its intended purpose. This can be performed either internally (at the same company), or, with the on-going increasing trend in outsourcing, to an external Contract Research or Development organisation (CRO or CDO).
More info >>

 
Industry Events

Nordic Life Science Days 10/12 September 2019

10-12 September 2019, Malmo Sweden

Nordic Life Science Days is the largest Nordic partnering conference for the global Life Science industry. Bringing together the best talents in Life Science, offering amazing networking and partnering opportunities, providing inputs and content on the most recent trends. Nordic Life Science Days attracts leading decision makers from the Life Science sector, not only from biotech, pharma and medtech but also from finances, research, policy and regulatory authorities.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement