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Global Patient Safety (GPS) Trial Master File (TMF) Specialist - Contractor

Redwood City, CA 94063

Posted: 04/17/2025 Employment Type: Contract Job Category: Pharmacovigilance Job Number: 618886 Is job remote?: Yes Country: United States

Job Description


Global Patient Safety (GPS) Trial Master File (TMF) Specialist - Contractor

The Opportunity:

As a Global Patient Safety (GPS) Trial Master File (TMF) Specialist, you will be the GPS TMF lead in the cross-functional management of TMF for clinical studies. The responsibilities will include the oversight of GPS vendors to ensure proper collection and filing of all safety documentation into the applicable eTMF platform.  

Responsibilities:

  • Serve as the GPS TMF lead in the cross-functional management of TMFs for all clinical studies.

  • Adhere to applicable Standard Operating Procedures (SOP), Good Clinical Practice (GCP), International Conference on Harmonization (ICH) Guidelines, and ALCOA+ principles.

  • Communicate TMF filing status to cross-functional teams to ensure study goals are met.

  • Co-author, review, and manage all all eTMF Plans, Index, applicable SOPs/guidance documents and associated documents as the GPS subject matter expert (SME).

  • Perform quality control of uploaded documents to ensure accurate uploading and proper indexing.

  • Establish and manage quality oversight of study TMFs, including TMF metrics and KPIs.

  • Partner with CROs/vendors and cross-functional team members to manage TMF activities, as needed.

  • Maintain vendor and internal processes for cataloging, filing, retrieving, saving and transferring TMF records.

  • Develop successful working relationships with CROs/vendors on TMF management.

  • Support audit and inspections for GPS TMF related activities.

  • Actively contribute in the eTMF uploads for all relevant clinical studies, as needed.

  • Participate in other GPS activities as appropriate.

Required Skills, Experience and Education:

  • Bachelor’s degree preferably in biological sciences or health-related field.

  • 2 years minimum of in depth TMF management experience within Pharmacovigilance/Safety.

  • Strong knowledge and understanding of international safety reporting regulations and safety reporting compliance.

  • A Strong working knowledge with the DIA TMF Reference Model or equivalent, ICH-GCP, ALCOA+ standard and regulatory requirements related to document management.

  • Proven ability to successfully oversee TMFs including development of relevant processes and policies.

  • Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace.

  • Excellent written/verbal communication, interpersonal skills and decision-making skills.

  • High sense of priority and commitment to excellence in the successful execution of deliverables.

  • Profient in SharePoint and various eTMF platforms such as Veeva, Trial Interactive, WingSpan, FLEX.

  • Proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.

  • Travel may be required, if remote (~25%).

Preferred Skills:

  • Experience working with CROs/vendors and management of external resources.

  • Oncology experience, early and/or late stage.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Redwood City, CA

Ready to embark on an exciting career opportunity in the vibrant area around Redwood City, California? Nestled in the heart of Silicon Valley, this thriving region offers a perfect blend of innovation, growth, and charm. From the bustling tech scene to the serene beauty of Redwood City's parks, like Edgewood Park and Pulgas Ridge Preserve, there's something here for everyone. Immerse yourself in the local culture by visiting the Fox Theatre or exploring art galleries like The Art Center and Redwood City Art Kiosk. With a bustling food scene offering everything from trendy cafes to authentic Mexican cuisine, it's no wonder that Redwood City is a top choice for job seekers looking to thrive in a dynamic environment. Browse our job listings today and take the next step towards a fulfilling career in this captivating locale!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.