Director, Trial Master File (TMF) Operations Job at EPM Scientific, Fremont, CA

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  • EPM Scientific
  • Fremont, CA

Job Description

Job Type: Full-time

Salary: $200K-$215K

Location: Hybrid - San Francisco Bay Area, CA / Jersey City, NJ / NY, NY

Company Summary: A pre-IPO clinical stage biotech developing therapies to treat cancer and autoimmune disease. Currently they are backed by VCs and have successfully raised nearly a $1 billion continue advancing their clinical programs.

The Opportunity: The Director, TMF Operations will lead TMF operations for all of the clinical trials across the organization. You will need to drive change and progress at a strategic level, and will therefore, need to possess the necessary communication and collaboration skills to ensure TMFs are complete, accurate, and compliant with regulations.

Responsibilities:

  • Leading the TMF Operations function to support Clinical Research and Development
  • Managing and overseeing the TMF Operations team, including hiring, training, and performance management
  • Maintaining strong relationships with TMF third party vendors, including driving resolution of issues and remediation activities
  • Develop and implement TMF processes and procedures, and TMF-related training materials that adhere to regulatory requirements and industry best practices
  • Develop and maintain strong relationships with internal stakeholders, including acting as a subject matter expert for TMF operations and requirements
  • Collaborate with cross-functional teams to ensure TMF completeness and accuracy throughout the trial lifecycle
  • Manage the quality control of TMF documents according to GCP and regulatory requirements from study start-up through inspection readiness and archival
  • Develop and establish TMF Key Performance Indicators (KPIs) globally for internal staff, CRO, and other stakeholders

An ideal candidate for this role MUST have…

  • Minimum of 12+ years of experience with a Bachelor's degree, or 10+ years of experience with a post graduate degree
  • Proven leadership experience in an insourced biotech organization
  • Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and industry best practices for TMF operations
  • Experience with electronic Trial Master File systems (e.g., Veeva) and related technology platforms

Benefits:

  • Pre-IPO biotech company
  • Competitive salary with comprehensive benefits (100% medical coverage)
  • 401K contribution

Job Tags

Full time,

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