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and scientists, who might not have a strong interest in or aptitude for managerial activities, can maximize their professional contribution to each project while leaving management to expert managers. This is fully consistent with the CRO's approach. |
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Because the CRO's project manager is generally responsible for primary communication with the sponsor's project leader, the project manager has a major influence on the success of the relationship between sponsor and CRO. Consequently, the manager assigned to a project is becoming an increasingly important determinant in the selection of a CRO by a sponsor. |
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Beginning with a launch meeting, as described above, the CRO's project manager must assure that all activities associated with the project have been identified and scheduled and that appropriate staff has been assigned to each task. Integral to the implementation process is the verification that the plan presented to the sponsor in the initial proposal is fully consistent with the sponsor's actual requirements. Substantive variations which have budget impact should be fully documented, budgeted, and approved by the sponsor to avoid misunderstandings during the project. Notably, the entire project team (sponsor and CRO) must understand and adopt the work plan to assure project success. |
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The CRO project manager must track project progress relative to the plan and report to the sponsor on a periodic basis, perhaps, as frequently as weekly and at least monthly. This evaluation of progress should be accompanied monthly by a financial review to assure that actual costs are consistent with the approved budget and that operational efficiencies are maintained. |
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The CRO project manager must communicate with the sponsor on all primary project initiatives and status and must also assure appropriate communication throughout the project team to coordinate the overall function of the team. |
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It is often essential that functional departments within the CRO, such as clinical monitoring, medical, or regulatory, communicate directly with their sponsor counterparts. In such an event, the project managers (CRO and sponsor) should be advised of any key decisions to assure that the project plan and/or budget will not be affected. If a change in work scope and budget are required, this should be documented formally and in a timely manner by the project manager and submitted to the sponsor for approval. A graphic representation of this typical communication model is shown in Fig. 2. |
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As discussed above, problems are likely to arise during the course of a project. Undoubtedly, the project manager will be required to take a |
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