Senior Clinical Trial Manager

1 month 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 

  • Bachelor’s 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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