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project management in pharmaceutical biometry and data ...

project management in pharmaceutical biometry and data ...

224

224 Martin Wilhelm FIGURE 3. Personal profile for the selection of project managers that refects the balanced characteristics and qualifications required for this task. the period of conception serves to find a cor- as marketing, medical services, etc.) have the porate compromise regarding the areas of ac- opportunity to articulate their requirements tivity, the desired output, and the tasks and and expectations for future data management objectives of project management. It is im- support and where the neccessary comproportant that the latter operations are antici- mises regarding cooperation, expected out- pated here and the cooperative partners and put, and the settling of budget questions can their organizational specifics (matrix or line be achieved. Taking this as a foundation the organization) are identified. Also very im- operative conception should be prepared in portant is the involvement of the top managment to create the required authority for the three steps: implementation. It is a common experience, 1. The entire spectrum of actual tasks of all however, that the search for compromises data management units should be analyzed across organizational units is a tough and and grouped to core business areas and long lasting business with a high risk of fail- activities. These are, for example: drug deure. Nevertheless, going the hard way is velopment, maintenance and support of strongly recommended because otherwise a marketed drugs, new methods and technol- matrix organization that must be embedded ogy, reengineering attempts, and so forth. in an existing corporate organism will never The core areas may vary from company work effectively. A successful approach may to company, lie in strategic workshops where the custom- 2. In the next step the hot spots within each ers of data management and biometry (such core area are sought that would give the

Project Management in Pharmaceutical Biometry and Data Management 225 best revenue for organizational invest- cooperating units. Therefore, in the first line, ment. They can be identified by meeting the organizational structure, the reporting one or more of the following criteria: long lines, and individual tasks of the project man- lasting, multiple interfaces, large investagers (at least one per data management site) ments (manpower/money), time consum- should be defined clearly and fixed. Whening with bad input/output ratio, collision ever a corporate data management depart- with other priorities, collision of responsi- ment with company-wide responsibilities bilities. At the end of this step the major exists, all project managers should report operation fields for the first activities of directly to the respective head. In general, project management are identified, and the link to the line management should be 3. According to these findings the required as high-ranking as possible to empower the methods to be applied by the matrix organ- project managers. Otherwise their efficacy, ization must be selected. To determine the especially when working on process im- most suitable ones, Figure 4 provides a provement or interface management, will be matrix of useful combinations. far less than optimal. Another strong empowerment is the control over the project bud- THE IMPLEMENTATION PHASE gets. In detail that means direct asignment of all planned project expenses directly to Implementation of project management the project managers and not to the line manmeans changes for the organization and indi- agement. Next, their tasks and competencies viduals in data management as well as in must be outlined and fixed in approved job FIGURE 4. Hot spots indicate those parts of the data management where PM intervention is required most urgently. The matrix above combines a given hot spot with PM methods (X) to be applied to manage the particular problems.

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