Trial Master File Specialist

Trial Master File (TMF) Specialist6-month initial contract (potential for extension & possible conversion to FTE)San Francisco Bay Area, CA (hybrid)ResponsibilitiesAct as the primary GPS TMF lead, coordinating cross-functional TMF management for clinical studiesFollow Standard Operating Procedures (SOP), Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and ALCOA+ standardsUpdate cross-functional teams on TMF filing progress to support study objectivesAs the GPS subject matter expert, draft, review, and oversee all eTMF Plans, Index, SOPs, and related documentsPerform quality checks on uploaded documents to ensure accuracy and correct indexingOversee the quality of study TMFs, managing TMF metrics and key performance indicators (KPIs)Collaborate with CROs/vendors and team members to coordinate TMF activitiesManage systems for cataloging, filing, retrieving, saving, and transferring TMF records for both internal and vendor processesBuild and maintain effective working relationships with CROs/vendors for TMF managementSupport GPS TMF-related audit and inspection activitiesContribute to eTMF uploads for applicable clinical studies, as neededEngage in other GPS functions as appropriateRequired Skills, Experience, and EducationBachelor's degree, ideally in biological sciences or a health-related fieldAt least 2 years of TMF management experience within Pharmacovigilance/SafetyStrong understanding of international safety regulations and compliance in safety reportingProficient in the DIA TMF Reference Model or equivalent, ICH-GCP, ALCOA+ standards, and document management regulationsDemonstrated ability to manage TMFs effectively, including developing related processes and policiesAbility to work well in collaborative, fast-paced team settings, adapting as neededExcellent communication, interpersonal, and decision-making skillsStrong commitment to prioritizing tasks and achieving deliverables with high standardsProficient 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 plusWillingness to travel up to 25%, if working remotelyPay rate$35 - $40/hr. W2Preferred Skills, Experience and EducationExperience working with CROs/vendors and management of external resourcesOncology experience, early and/or late stage

Created: 2024-11-09