TMF Specialist, Global Patient Safety

TMF Specialist, Global Patient SafetyW2 Contract-to-HirePay Rate: $40 - $60 per hourLocation: Redwood City, CA - Hybrid RoleJob 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+ municate TMF filing status to cross-functional teams to ensure study goals are met.Co-author, review, and manage all eTMF Plans, Index, applicable SOPsguidance 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 CROsvendors 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 CROsvendors 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 field2+ years of in-depth TMF management experience within Pharmacovigilance and SafetyStrong knowledge and understanding of international safety reporting regulations and safety reporting complianceStrong working knowledge of the DIA TMF Reference Model or equivalent, ICH-GCP, ALCOA+ standard, and regulatory requirements related to document managementProven ability to successfully oversee TMFs, including the development of relevant processes and policiesThrives in a collaborative team setting that demonstrates flexibility required to maintain a fast paceExcellent written and verbal communication, interpersonal skills, and decision-making skillsHigh sense of priority and commitment to excellence in the successful execution of deliverablesProficient with SharePoint and various eTMF platforms such as Veeva, Trial Interactive, WingSpan, and FLEXProficiency in Microsoft Office Suite, including Outlook, Word, Excel, and PowerPoint; MS Project and Smartsheet is a plusTravel may be required (~25%)Experience working with CROsvendors and management of external resources is preferred.Oncology experience, early andor late stage, is a plus.Desired Skills and ExperienceGlobal Patient Safety, Trial Master File, SOPs, GCP, ICH Guidelines, ALCOA+, SharePoint, eTMF, Veeva, Trial Interactive, WingSpan, FLEX, Microsoft Office, Smartsheet, vendors management, Oncology, travelBayside 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

Created: 2024-11-02