TMF Specialist, Global Patient Safety

4 weeks ago

Fremont, California, United States Bayside Solutions Full time

Job Summary:

As a Global Patient Safety (GPS) Trial Master File (TMF) Specialist, you will lead the cross-functional management of TMF for clinical studies. You will oversee GPS vendors to ensure proper collection and filing of all safety documentation into the applicable eTMF platform. Travel may be required up to 25% of the time.

Duties and 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 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 audits and inspections for GPS TMF-related activities.
  • Actively contribute to eTMF uploads for all relevant clinical studies, as needed.

Requirements and Qualifications:

  • Bachelor's degree, preferably in biological sciences or a health-related field
  • 2+ years of in-depth TMF management experience within Pharmacovigilance and Safety
  • Strong knowledge and understanding of international safety reporting regulations and safety reporting compliance
  • Strong working knowledge of 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 the development of relevant processes and policies
  • Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace
  • Excellent written and verbal communication, interpersonal skills, and decision-making skills
  • High sense of priority and commitment to excellence in the successful execution of deliverables
  • Proficient with SharePoint and various eTMF platforms such as Veeva, Trial Interactive, WingSpan, and FLEX
  • Proficiency in Microsoft Office Suite, including Outlook, Word, Excel, and PowerPoint; MS Project and Smartsheet is a plus
  • Travel may be required (~25%)
  • Experience working with CROs/vendors and management of external resources is preferred.
  • Oncology experience, early and/or late stage, is a plus.

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

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.

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