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necessary. Some companies (more commonly smaller start-up ones) pride themselves in employing only Ph.D.s and postgraduate-qualified physicians to run clinical trials. This reflects the specialist nature of these companies, but, as they develop, they usually take on new projects outside their original technical specialties. Are they going to replace all the project staff as they do this? In fact, they manage very well with their existing people, who turn out to be more adaptable than they thought. Thus, very many Ph.D.s in pharmaceutical clinical development are working outside the subjects of their theses. It should be understood here that we are discussing the project management rolethere will of course always be a need for specialists within multidisciplinary project teams, and such specialists commonly become project managers in their own right because of their management skills rather than technical expertise. |
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These skills include the ability to take in a situation in breadth, looking for interfaces between seemingly unconnected issues. This, coupled with tenacity under stress, builds a culture of forward-looking managementpredicting problems, minimizing the need to find scapegoats, and always working toward attaining the project targets on time. Interpersonal skills are also vital, and these come into play at every stage from project design, when agreements between various disciplines have to be negotiated, to the collection of accurate progress information. |
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The structure for protocol development shown at the beginning of this chapter is typical of procedures commonly used in the pharmaceutical industry. It complies with good clinical practice (GCP), and, assuming all the correct data are passed down the line, would be expected to generate a workable protocol. This is not always the case because of its unidirectional design. A list of requirements at the outset is unlikely to be complete, and, unless this list is challenged by the recipient, gaps may remain unfilled, or even worse, may be filled by guesswork. A more secure system is shown in Fig. 7, which is successfully used by the author for all types of work related to clinical trials. The essence is that at the functional requirements stage (what the client wants from the project) and at the selection of methodology stage, two-way communication with the client is the rule. Tools which help this process are already largely available in the form of SOPs to check feasibility and databases of information on how methods performed in the past, to name but two. A project manager with a good grasp of this process should be able to define any project within his span of technical knowledge, |
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