Tmf Associate

Summary

Join Alimentiv as a TMF Associate in Toronto, working remotely, for a limited-term contract (March 2025 - May 2026). You will manage Trial Master File (TMF) content and processes throughout the study lifecycle, ensuring completeness and inspection readiness. Collaborate with study teams on file reviews and audits, manage the electronic file repository, and proactively contribute to a cross-functional team. Responsibilities include serving as the primary TMF contact for assigned studies, creating study-specific TMF documents, maintaining quality control, and providing training. The role also involves department support tasks and contributing to system improvements. The salary range is $52,500 - $87,500 CAD.

Requirements

• Possess a college diploma/degree and 1-3 years of relative related experience or ongoing training
• Have an understanding of TMF organization, implementation, and archival including relevant regulations and guidance to assure quality and integrity of TMFs
• Have 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

Responsibilities

• 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
• 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

Benefits

Remote work