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Scientific. Clinical. Engineering

Clinical Trial Manager

New York City Metro Area, NY

Employment Type: Full-Time Job Type: Clinical Job Number: JN -082022-30757 Region: New York City Metro Area

Job Description

Required Skills & Experience:

  • Minimum of 3 years of Clinical Trial Management experience for a sponsor company or CRO within the area of Oncology.
  • Detailed understanding of clinical development within Phase I, II or III clinical trials
  • Supervision and management of various activities within clinical studies in accordance with ICH/GCP. FDA-CFR.
  • BA/BS ideally in a Scientific background

Responsibilities:

  • Manages efforts in study start-up, including study feasibility, site selection, preparation and follow-up of site regulatory packages in coordination with other clinical operation staff
  • Designs or assists in the development of study related documents including but not limited to: protocol, case report forms, case report form completion guidelines.
  • Contributes to development of clinical outsourcing specifications (as required) to facilitate bid process and selection of Contract Research Organizations (CROs); manages interface with CROs in cooperation with line functions; ensures vendors meet quality standards in their work for the trial; contributes to the development/amendment of vendor contracts.
  • Acts as initial point of contact for all site-related issues and procedural questions.
  • Core member of the global cross-functional Clinical Trial Team (CTT); reports study progress and issues/resolution plan at the CTT meeting; writes CTT meeting minutes.

*Experienced candidates only please.

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