TMF Specialist - 174885

Responsibilities: of the TMF Specialist include: · Managing TMF set-up, quality oversight, reporting, metrics, and quality control activities · Maintaining overall TMF document quality and completeness, including proper filing, coordination, tracking, and reporting · Ensuring clinical trial documentation complies with eTMF specifications, ICH/GCP guidelines, regulatory requirements, and internal SOPs · Accurately maintaining all TMF records in accordance with SOPs and data standards to support inspection readiness · Responding to client requests for TMF retrieval, reproduction, re-filing, and delivery of electronic records · Supporting the development and maintenance of TMF training materials, SOPs, and guidelines, including training staff as needed · Assisting with audit and inspection readiness activities and ensuring the TMF remains inspection ready · Staying current on TMF Reference Model standards, regulatory requirements, and industry best practices · Serving as a liaison between eTMF records management and internal and external clients · Monitoring project activities to ensure deadlines and deliverables are met · Acting as a subject matter expert on TMF-related matters and providing guidance to project staff and subcontractors · Performing quality control reviews of TMF documents to ensure accuracy · Coordinating retrieval of requested records and preparing closed studies for transfer within agreed timelines · Assisting management with records management planning, cost proposals, and resource forecasting · Performing task management and, depending on experience level, line management responsibilities Qualifications: for the TMF Specialist include: · Experience working with eTMF systems; Veeva Vault or Trial Interactive preferred · Strong understanding of clinical research processes and document management requirements · In-depth knowledge of ICH-GCP guidelines and regulatory requirements related to TMF management · Excellent organizational skills with strong attention to detail · Effective written and verbal communication skills · Ability to manage multiple priorities in a fast-paced, deadline-driven environment · Strong problem-solving and analytical skills · Experience advising project teams on TMF-related issues · Experience training, mentoring, and coaching staff · Ability to build and maintain positive working relationships across teams and management · Proficiency in Microsoft Office · Bachelor's degree in a science or healthcare-related field required Compensation: for TMF Specialist includes: · Rate Range: $20-35/hr · Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law This job is open for applications on October 6th, 2026. Applications will be accepted for at least 30 days from the posting date.