|
|
|
|
|
|
|
I.
Multidisciplinary Teamworking |
|
|
|
|
|
|
|
|
Earlier we emphasized the multidisciplinary nature of modern drug development. So diverse are the skills required, that understanding between the skill holders may be incomplete. Therefore, the project manager must be a generalist, appreciating (but not necessarily understanding in-depth) a wide range of technical issues. This begs the question of who is really in charge. As we have already seen, transfer of data from one stage to the next is less successful if the authority is transferred abruptly at the same timecontinuity is essential. One approach, used in passing manufacturing methods from phase I onward, is to involve the later phase specialists as observers and advisers in the early-phase teams, and vice versa. However the key lies in lines of authorityto whom should the project managers report? It will be argued here that they should report to top management. If they report to anyone else, how can their authority be real? |
|
|
|
|
|
|
|
|
II.
A New World of Clinical Research |
|
|
|
|
|
|
|
|
A.
Projects versus HierarchiesNew Solutions |
|
|
|
|
|
|
|
|
The most desirable type of project organization and simplest to implement is the self-contained project, which can be treated almost as a separate company. However, this can be justified only if the team members are spending most of the time on the one project. More realistically, people are shared between projects, and then, it makes sense for people to be allocated to project teams by agreement with their functional heads. These agreements need to be clear, usually in writing, and once agreed, the functional head must not override it. Therefore, a key function of the project manager is to negotiate these agreements and ensure that top management supports compliance with them. A somewhat looser structure is also possible, where staff are simply rented from departments and allocated to projects, as many companies use contracted-in staff. Whatever the structure, how the staff time is paid for needs to be agreed on, but in practice this is rarely monitored in pharmaceutical development so that the real cost of an individual project is difficult to measure. This is the reason that CRO work sometimes looks expensive. |
|
|
|
|
|
|
|
|
1.
Who Is the New Clinical Project Manager? |
|
|
|
|
|
|
|
|
There is a welcome trend in pharmaceuticals toward a flatter management structure, with the project teams receiving more prominence than fixed hierarchies. Nevertheless, departmental heads generally have more status |
|
|
|
|
|