Director Clinical Trial Management

95643_1707226013
  • $190000 - $210000 per anuum
  • New York
  • Permanent

Summary of Responsibilities

  • 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

Education, Qualifications, and Experience

  • 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
Marc Roessle Team Lead

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