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and benefits than project managers, and the latter, if successful, may be offered promotion to run a department. Here, we will suggest an alternative view because clinical projects are challenging and require very special skills. In fact, they are so demanding that successfully completing clinical projects on time may be more difficult than running a department! The scenario of a departmental head being promoted to project manager is not to be discounted. |
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2.
Candidates for Project Responsibility |
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Although much progress is being made, the true definition of the project manager's role is still emerging. Projects may be managed by people holding the titles of pharmaceutical physician, clinical research associate, project coordinator, clinical trials manager, among many others. Conversely, some project managers do not actually manage projects, but may only provide services to people who do. Whatever the title, the same skills and functions will be involved, but there is the danger that project responsibility will be thrust upon individuals without the right training or experience or without the authority required to get things done. |
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In this context, perhaps the most difficult of the roles outlined above is the project coordinator. As this implies, this individual has to do all the work of negotiating plans, but has none of the authority to ensure compliance with plans. It is a very common management structure, and, in most applications, usually the worst structure to choose. It can be made to work, but only if the coordinator receives authoritative backup from elsewhereotherwise, what is the point of good planning if people can default on agreements without sanctions? |
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3.
Approaches to Project Organization |
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Some companies are responding creatively to these challenges by implementing more rational organizational structures. For example, it is recognized that people who have prolific ideas are generally less effective at executing them. An approach being tried now with some success is to accept that it is difficult to change a person's fundamental nature, so the clinical research function is divided into two groups. One group generates ideas and refines them into workable projects, and then, these are passed to the other group with the skills to carry out the projects. The danger lies in effective transfer of the project from one group to the otherindeed this applies at many stages throughout the R & D process. Therefore, the team members who execute the plan must be involved in its design. A similar problem can occur when a drug moves between clinical phases. For |
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