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Remote TMF Operations Lead: Inspection-Ready Trials

Praxis Precision Medicines, Inc.

Boston, MA
  • Remote job

Praxis Precision Medicines is seeking a TMF Operations Lead to ensure trial documentation is complete, accurate, and inspection-ready. You will partner with Clinical Operations and cross-functional teams to build high-quality TMFs and address risks early. This role requires 5+ years in TMF management, deep knowledge of ICH-GCP and FDA requirements, and experience with electronic TMF platforms (Veeva Vault preferred). #J-18808-Ljbffr Praxis Precision Medicines, Inc.

Vacancy posted 3 days ago
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