Trial Master File Specialist

Trial Master File (TMF) Specialist 6-month initial contract (potential for extension & possible conversion to FTE) San Francisco Bay Area, CA (hybrid) Responsibilities Act as the primary GPS TMF lead, coordinating cross-functional TMF management for clinical studies Follow Standard Operating Procedures (SOP), Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and ALCOA+ standards Update cross-functional teams on TMF filing progress to support study objectives As the GPS subject matter expert, draft, review, and oversee all eTMF Plans, Index, SOPs, and related documents Perform quality checks on uploaded documents to ensure accuracy and correct indexing Oversee the quality of study TMFs, managing TMF metrics and key performance indicators (KPIs) Collaborate with CROs/vendors and team members to coordinate TMF activities Manage systems for cataloging, filing, retrieving, saving, and transferring TMF records for both internal and vendor processes Build and maintain effective working relationships with CROs/vendors for TMF management Support GPS TMF-related audit and inspection activities Contribute to eTMF uploads for applicable clinical studies, as needed Engage in other GPS functions as appropriate . Required Skills, Experience, and Education Bachelor’s degree, ideally in biological sciences or a health-related field At least 2 years of TMF management experience within Pharmacovigilance/Safety Strong understanding of international safety regulations and compliance in safety reporting Proficient in the DIA TMF Reference Model or equivalent, ICH-GCP, ALCOA+ standards, and document management regulations Demonstrated ability to manage TMFs effectively, including developing related processes and policies Ability to work well in collaborative, fast-paced team settings, adapting as needed Excellent communication, interpersonal, and decision-making skills Strong commitment to prioritizing tasks and achieving deliverables with high standards Proficient in SharePoint and various eTMF platforms (e.g., Veeva, Trial Interactive, WingSpan, FLEX) Skilled in Microsoft Office (Outlook, Word, Excel, PowerPoint); knowledge of MS Project or Smartsheet is a plus Willingness to travel up to 25%, if working remotely Pay rate : $35 - $40/hr.

W2 Preferred Skills, Experience and Education Experience working with CROs/vendors and management of external resources Oncology experience, early and/or late stage

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