TMF Manager

About the Role - This position reports into a Sr. Manager or Associate Director of Clinical Operations (or above). This role maintains TMFs ensuring they are current and inspection-ready for internal and external entities. The right candidate will possess an understanding of clinical trial conduct, TMF structure (DIA Reference Model), eTMF systems, and best documentation practices. Responsibilities - Responsible for managing clinical document quality/control/filing, and the Trial Master Files (TMFs). Performs set up activities, document filing and oversight of internal e/TMF applications. Supports Clinical Operations Study Leaders in the QC and oversight of CROs’ e/TMF applications. Functional lead for specified e/TMF platform with vendor(s). Provide support and guidance to CROs and support staff to ensure accurate and timely eTMF filing and maintenance according to ICH GCP guidelines. Provide training to eTMF users and external parties (CROs). Partner with management and others to support functional and organizational initiatives, to drive new procedures and ideas, and to function as an advocate for processes and decisions. Supports the development and review of standard operating procedures and work instructions related to clinical document management, as appropriate. Creates and maintains written instructions, SOPs, guidelines and plans as they relate to e/TMFs and document control. Updates and maintains Naming and Filing Guide(s) for relevant e/TMF systems. Work in collaboration with all applicable functional areas. Work in collaboration with Clinical Operations Management to drive new procedures and processes within the department, as appropriate. Qualifications - Bachelor’s degree or equivalent combination of education/experience in science or health- related field. Minimum 5 years of e/TMF experience for a pharmaceutical, biotechnology company, or contract research organization. Thorough knowledge of all sections of the DIA Reference Model (current version). Thorough knowledge of documents from various functional areas and their appropriate e/TMF filing requirements. Thorough knowledge of International Council for Harmonization (ICH) Good Clinical Practice (GCP) as well as Good Documentation Practice (GDP) principles. Required Skills - Experience with eTMF system or software to include but not limited to development of SOPs, user training manual, performing UATs and validations, etc. Thorough knowledge of electronic TMF application(s), for major non-proprietary system(s) and ability to prioritize related tasks based on project goals.