Senior Clinical Trial Manager

6 days ago


Cambridge, Massachusetts, United States Beam Therapeutics Inc. Full time
Senior Clinical Trial Manager

Beam Therapeutics Inc. is a pioneering company in the field of precision genetic medicines. We are seeking a highly experienced Senior Clinical Trial Manager to join our team and lead the cross-functional team through all day-to-day activities within the clinical trial life cycle.

Key Responsibilities:
  • Manage all trial start-up, conduct, and close-out activities to both industry and corporate standards within ICH/GCP Guidelines.
  • Work with Outsourcing and Contracts Management to ensure Site Contracts reflect trial activities and related budget.
  • Contribute to the development of Informed Consent Forms and provide oversight and approval for all country and site level ICFs in collaboration with the CRO.
  • Develop and maintain trial plans and site-facing documents.
  • Support data management activities, including reviewing study-related support materials created by Data Management.
  • Monitor vendor metrics and vendor performance, including KPIs, review of Monitoring Reports for content and compliance.
  • Organize and oversee all study-related meetings, including Investigator teleconferences and Clinical Study Team meetings.
  • Develop and maintain the Trial Master File, ensuring the final TMF is final and audit-ready at the close of the study.
Requirements:
  • Bachelor's Degree in a related field with 10+ years' experience in the biotech and/or pharmaceutical industries managing clinical trials.
  • Phase I experience is preferred.
  • Experience with GCP/ICH Guidelines and a strong understanding of cross-functional clinical processes.
  • Exceptional organizational skills and ability to deal with competing priorities.
  • Ability and willingness to travel up to 20% (domestic and international).


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