TMF Specialist, Global Patient Safety Lead

3 weeks ago


Santa Clara, California, United States Bayside Solutions Full time

Job Summary:

We are seeking a highly skilled TMF Specialist to lead the cross-functional management of Trial Master Files for clinical studies. As a key member of our team, you will oversee vendors to ensure proper collection and filing of safety documentation into the eTMF platform.

Duties and Responsibilities:

  • Manage TMF activities, including quality control and oversight, to ensure accurate uploading and proper indexing.
  • Develop and maintain quality processes for cataloging, filing, retrieving, saving, and transferring TMF records.
  • Partner with CROs/vendors and cross-functional team members to manage TMF activities.
  • Support audits and inspections for GPS TMF-related activities.
  • Contribute to eTMF uploads for all relevant clinical studies.

Requirements and Qualifications:

  • Bachelor's degree in biological sciences or a health-related field.
  • 2+ years of in-depth TMF management experience within Pharmacovigilance and Safety.
  • Strong knowledge of international safety reporting regulations and safety reporting compliance.
  • Proficient with SharePoint and eTMF platforms such as Veeva, Trial Interactive, WingSpan, and FLEX.
  • Excellent written and verbal communication, interpersonal skills, and decision-making skills.


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