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TMF Specialist, Global Patient Safety

2 months ago

Fremont, California, United States Bayside Solutions Full time
Job Summary

We are seeking a highly skilled TMF Specialist to join our Global Patient Safety team. As a key member of our team, you will be responsible for leading the cross-functional management of Trial Master Files (TMFs) for clinical studies.

Key Responsibilities
  • Oversee the collection and filing of safety documentation into the eTMF platform.
  • Collaborate with cross-functional teams to ensure study goals are met.
  • Develop and manage eTMF plans, indexes, and associated documents.
  • Perform quality control of uploaded documents.
  • Establish and manage quality oversight of study TMFs.
  • Partner with CROs and vendors to manage TMF activities.
  • Maintain vendor and internal processes for cataloging, filing, retrieving, saving, and transferring TMF records.
Requirements and Qualifications
  • Bachelor's degree in biological sciences or a health-related field.
  • 2+ years of experience in TMF management within Pharmacovigilance and Safety.
  • Strong knowledge of international safety reporting regulations and safety reporting compliance.
  • Proficient in SharePoint and eTMF platforms such as Veeva, Trial Interactive, WingSpan, and FLEX.
  • Excellent written and verbal communication skills.
  • Ability to work in a collaborative team environment.
Desired Skills and Experience

Global Patient Safety, Trial Master File, SOPs, GCP, ICH Guidelines, ALCOA+, SharePoint, eTMF, Veeva, Trial Interactive, WingSpan, FLEX, Microsoft Office, Smartsheet, vendors management, Oncology, travel.