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The project leader needs to ensure that project plans are well thought out, transparent to the organization, aggressive in time-to-market projections, have the backing of the various functional departments, and, if successful, support the achievement of the desired target profile/package insert. |
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By utilizing appropriate planning and control systems in his project, the successful project leader demonstrates leadership capability and creates and manages a myriad of mechanisms critical to the project leader and team throughout the drug development process. It is critical that, whatever tools are agreed upon to accomplish this objective, they are user friendly, useful to the project leader and the project team, and accessible to and used by all members of the team and others in the organization. It is anticipated and expected that these tools enable the team to develop integrated and aggressive project development plans with appropriate intermediate milestones and also ensure that the planning process is thorough enough to avoid downtime between critical path activities. |
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Project plans and schedules, which can be agreed upon, are critical prerequisites for obtaining individual commitments on projects. The project leader, team member, and functional manager must collectively know what tasks are committed to and when functional resources are required to perform and complete tasks as scheduled. For those individuals involved, progress on project plans must be appropriately monitored so that individual team members do not feel that their every working moment is being scrutinized by their organization. In addition, plans and schedule changes must be communicated to the organization periodically to ensure that all contributors stay aligned with project goals and performance expectations. Changes do indeed occur throughout development; it is imperative therefore that the project leader quickly communicate program modifications so that there are no unexpected surprises or misunderstandings with those whose commitments are affected by these changes. |
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To effectively lead a team, the team leader should be comfortable with and proficient in various planning, scheduling, and monitoring procedures and with mechanisms for developing budget estimates and control procedures. Project control is achieved in various ways, i.e., by setting mutually agreed objectives and goals, defining the various tasks which need to be performed, scheduling the tasks in concert with the functional departments in terms of resource requirements and availability, measuring project progress and performance in a clear, unbiased, and transparent manner, taking corrective action when progress is not made or when things do not go as |
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