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頂尖生技顧問股份有限公司

Clinical Project Manager

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Description

  • Manage and direct the efforts of CRAs assigned to project. Manage performance, scheduling and work assignments
  • Financial management: monitor expenditure of funds relative to budgetary targets for assigned trials on an ongoing basis.
  • Ensure that variances are identified and communicated to the appropriate personnel in a timely manner.
  • To independently manage/handle assigned clinical study.
  • Prepare the study budget in consultation with project management/line manager/business development for the assigned projects.
  • Prepare the project/monitoring plan for the study/ies. Track and ensure that project timelines and milestones are being met. Maintain and update all trackers to evaluate the progress of the study.
  • Suggest and facilitate contingency planning and implementation in order to meet timelines.
  • Implement the initiation of the study sites, with the appropriate follow up (co-monitoring, reviewing of reports, recruitment tracking) and close out (archiving of files, collecting of IP and trial materials) of study centers on the assigned projects.
  • Lead and supervise the CRAs in activities for the clinical studies, delegate tasks commensurate with skill levels while increasing knowledge base.
  • Assist in preparation of dossier and/or appropriate documentation for regulatory/ethics committee submission or other appropriate bodies on time as per required format.
  • Provide creative solutions for issues impacting study and team members.
  • Act as a key operational interface in the management of clinical studies.
  • Provide clinical research expertise in support of other departments and line functions.
  • Complete all assigned tasks by upper manager request.

You will need to be comfortable collaborating and communicating with a variety of colleagues and customers.

Skills

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See also

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