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Responsible for the management of the Trial Master File (TMF) content and associated processes during the study life cycle from study set up to transfer/archiving. Work in partnership with study teams during periodic file reviews and audits to address findings related to the TMF. Manage access and organization of the controlled electronic file repository, in line with the defined file structure and access management framework. Work proactively and successfully within a cross-functional team. Communicate and promote department and company goals and practices. Interact with stakeholders in a way that fosters a positive working atmosphere and encompasses a professional and helpful attitude. Time allocated may be adjusted based on need.
Service Delivery
- Serve as the primary TMF contact for assigned studies.
- Ensure TMF is complete and “inspection ready” throughout study lifecycle and documents are filed contemporaneously.
- Work with Team Lead to create study specific TMF management and oversight documents (e.g., File Index, Expected Document Lists and TMF Management Plan) in alignment with study.
- Develop and maintain study-specific work instructions, as needed.
- Utilize organization skills to maintain a quality control schedule and perform periodic inventories of study TMF to ensure completeness.
- Review and communicate out-of-scope and/or incomplete documents to study teams; escalating as needed.
- Reconcile expected document lists based on study events and milestones.
- Prioritize and resolve TMF help desk tickets; may include triaging activities.
- Provide study specific TMF training to internal and/or external stakeholders, as needed.
- Process and review documents, following applicable scanning and best practices and best practices, and applying ALCOA principles appropriately.
- File and retrieve TMF documents in a timely manner.
Department Support
- Complete routine administrative tasks in a timely manner (e.g., timesheets, metrics).
- Participate in discussions, decisions and sharing of knowledge in department meetings, periodic presentations, and smaller working groups.
- Seek opportunities to assist in the development, implementation and maintenance of internal systems (e.g., databases used to manage records).
- Provide mentorship and training to junior level staff.
- Propose suggestions and work on the development and maintenance of department quality system documents to improve efficiencies.
Qualifications
- The successful candidate will possess a college diploma/degree and must have 3-5 years of TMF oversight experience in managing mutliple studies at once.
- A strong understanding of TMF organization, implementation, and archival including relevant regulations and guidance to assure quality and integrity of TMFs.
- The ability to incorporate the principles of ALCOA in relation to TMF oversight.
- Utilize skills in time management and problem-solving. Identify challenges and problems and take the initiative to identify solutions.
- Demonstrated computer literacy, proven functional knowledge of Microsoft packages and potential to develop.
Working Conditions
- Home based, with the ability to go into office when needed.
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