Senior Trial Master File Manager

Job Title: Senior Trial Master File Manager

Company: Biopharma

Location: Durham, NC

Brio Resource Group is a Life Sciences Executive Search Firm committed to providing rare talent on an exclusive search basis to the Biopharma, Pharma, Device and CRO industries. We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging Biopharma companies offering life-changing therapies. Our many years of experience, subject matter expertise, comprehensive search process and genuine passion to deliver rare talent defines Brio.

Position Overview:

​As a Senior Trial Master File Manager, you will be responsible for being the main point of contact for any and all activities associated with the organizations TMF’s ensuring that they meet Health Authorities/Regulatory Agencies expectations and compliance.

Opportunity Highlights:

  • Oversee the training and development of eTMF/CTMS systems
  • Ensure compliance of TMF filings across all of the organization’s studies through the monitoring of TMFs metrics
  • Work cross-functionally with CTM’s (Clinical Trial Manager’s) to create TMF Plans with their associated timelines
  • Review the Trial Master File periodically to ensure its cooperation with CTM’s
  • Ensure that the TMF procedures are up-to-date and reflect industry standards and guidance

Position Requirements: Associate or Bachelor’s Degree Required

  • 5+ years’ experience in a clinical development environment
  • 3+years’ experience with TMF management
  • Deep knowledge of GCP and ICH guidelines
  • Deep knowledge of FDA and EU guidelines

We welcome the opportunity to provide a full job description upon resume review.

How to Apply:

In order to be considered for the above opportunity, simply apply via LinkedIn and include your CV.

We respond to applicants who meet our position requirements, but suggest submitting your resume for future consideration for our expanding list of new opportunities surfacing daily within our Biopharma network. We have a strict honor code at Brio respecting your confidentiality and we only share your information with your consent.

Brio Resource Group, LLC considers all applicants without regard to race, color, religion, sex, national origin, age, mental or physical disabilities, or any other similarly protected status.