TMF Associate

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.