Global Patient Safety TMF Specialist

Global Patient Safety TMF Specialist

W2 Contract

Salary Range: $104,000 - $114,400 per year

Location: Redwood City, CA - Hybrid or Remote

Job Summary:

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. You will oversee GPS vendors to ensure proper collection and filing of all safety documentation into the applicable eTMF platform.

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.
• 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 to the eTMF uploads for all relevant clinical studies, as needed.
• Participate in other GPS activities as appropriate.

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/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 developing relevant processes and policies.
• Thrives in a collaborative team setting, demonstrating the 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 successfully executing deliverables.
• Proficient in SharePoint and various eTMF platforms such as Veeva, Trial Interactive, WingSpan, and 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%).
• Experience working with CROs/vendors and management of external resources is preferred.
• Oncology experience, early and/or late stage, is preferred.

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

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