Senior Clinical Trial Manager

3 weeks ago


Princeton, United States TK-CHAIN LLC Full time
Job DescriptionJob Description
  • Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations

  • Serve as primary Sponsor contact for operational project-specific issues and study deliverables

  • Maintain in depth knowledge of protocol, therapeutic area, and indication

  • Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is

  • provided

  • Review and provide input for study protocol, edit check specifications, data analysis

  • plan, and final study report, when applicable

  • Develop operational project plans

  • Manage risk assessment and execution

  • Manage study vendors where applicable

  • Manage site quality and monitoring deliverables

  • Skills and experience required

  • Bachelors degree in a health-related field; Advanced degree in a health-related field preferred

  • Experience in Phases 1-4; Phases 2-3 preferred

  • 5+ years as a project/clinical trial manager within a CRO

  • Management of overall project timeline

  • Bid defense experience

  • Strong leadership skills




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