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unless it is absolutely necessary. From this perspective, the alliance project team should be in harmony as to what needs to be done, who is going to do it, and when it will be done. |
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The alliance project leader, however, can be set up to fail, either intentionally or unintentionally. Both partners have to accept the role and responsibility of the project leader with freedom to do the job. If the following are not defined or accepted by both organizations for the project leader, the team and team leader will have little chance to succeed: |
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a role that is well defined and clearly communicated; |
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defined scope of responsibility, authority and accountability, accepted or reinforced (i.e., when ever a problem arises that is brought to line management, the line manager redirects the problem to the project leader rather than solving it themselves); |
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well-defined decision making responsibility; and |
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clear mechanism for budgetary control and/or direct influence. |
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Overall, the success of a project leader depends on the ability to influence, which depends on credibility and trust built on mutual respect. |
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The team structure/membership is always a challenge, especially with an alliance partner. In many cases, in an attempt not to offend anyone, teams become inordinately large, with duplicate experts from both organizations as members. In itself, this is a dysfunctional team. It is always beneficial to keep teams small. Therefore, from an overall project management perspective, an alliance project team structure can be viewed as multiple teams, governed by a common core team, headed by the project leader. The core team should include a clinical leader, a nonclinical leader with responsibility for all nonclinical functions, a regulatory affairs leader, local project managers (if they exist), and a marketing leader. Manufacturing representation should be added at the appropriate time within a project's development life cycle. As is the case with many of the nonclinical functions, their level of input and/or their required input waxes and wanes over the time course of the project. In some cases and at some times, manufacturing and some of the nonclinical functional areas can be viewed as agenda team members whose representation is required for a specific agenda topic or part of a project's development. In any case, it is imperative to ensure that the right people are available at the right time to give the best input. |
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Each of the core team members then leads a technical area specific team, which has input to the core team through its leaders or core team agenda members, as appropriate. The overall scheme of the core team and its affiliate teams is described in Fig. 1. |
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