Senior Clinical Trial Manager

4 weeks ago


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

Beam Therapeutics Inc. is seeking a highly experienced Senior Clinical Trial Manager to lead the cross-functional team through all day-to-day activities within the clinical trial life cycle. The successful candidate will have a strong understanding of GCP/ICH Guidelines and a proven track record of managing clinical trials from start-up to close-out.

Key Responsibilities:
  • Manage all trial start-up, conduct, and close-out activities to industry and corporate standards.
  • 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.
  • Develop and maintain trial plans and site-facing documents.
  • Support data management activities, including reviewing study-related support materials and participating in data cleaning activities.
  • Monitor vendor metrics and performance, including KPIs and deviation reporting.
  • Organize and participate in study-related meetings, including Investigator teleconferences and Clinical Study Team meetings.
  • Develop and maintain the Trial Master File, ensuring it is final and audit-ready at the close of the study.
Qualifications:
  • 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.
  • Strong understanding of cross-functional clinical processes and GCP/ICH Guidelines.
  • 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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