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Clinical Trial Manager

New Jersey All, NJ

Post Date: 07/10/2018 Job ID: JN -072018-22021 Job Type: Clinical
  • Provide oversight on study activities to ensure progress according to study timelines
  • Ensure proper documentation availability
  • Ensure proper collection and validation of data and documentation on a timely manner
  • Organize and lead study meetings
  • Collect, synthesize and report study information
  • Collaborate with the Clinical Supplies Platform to validate Investigational Medicine Product (IMP) needs, specifications, packaging, shipment (including resupply) and reconciliation process
  • Participate in selection and management of vendors, development/follow-up of the associated budget
  • Preparation and oversight of study audits/inspections both internal and external
  • Provide oversight and preparation for FDA pre-approval inspections (PAI)
  • Work cross-functionally fostering team spirit and team motivation
  • Develop and maintain an optimized study planning with other functions (including identification of critical path)
  • Coordinate multiple interfaces, both internally and externally
  • Anticipate, timely escalate issues and to define appropriate action plans
  • Participation to routinely data management activities and oversight, data review and analysis (clinical operational) to propose actions and a remediation plan
  • May assist trainees/Clinical Trial Assistant/Trial Management Assistant and/or new comers in their self-development (project-related activities)

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