TMF Associate

3 weeks ago

Halifax, Canada Alimentiv Full time

Base pay range CA$52,500.00/yr - CA$87,500.00/yr Responsibilities Manage the Trial Master File (TMF) content and associated processes during the study life cycle from study setup to transfer/archiving. Partner with study teams during periodic file reviews and audits to address findings related to the TMF. Organize the controlled electronic file repository in line with the defined file structure and access management framework. Communicate and promote department and company goals and practices within a cross‑functional team. Foster a positive working atmosphere with a professional and helpful attitude when interacting with stakeholders. Service Delivery Serve as the primary TMF contact for assigned studies. Ensure the TMF is complete and “inspection ready” throughout the study lifecycle and documents are filed contemporaneously. Collaborate with the 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 the study. Develop and maintain study‑specific work instructions, as needed. Utilize organizational skills to maintain a quality control schedule and perform periodic inventories of the 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, 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 College diploma/degree and 1‑3 years of related experience or ongoing training. Strong understanding of TMF organization, implementation, and archival including relevant regulations and guidance to assure quality and integrity of TMFs. Ability to incorporate the principles of ALCOA in relation to TMF oversight. Proficiency in time management and problem‑solving; identify challenges and take initiative to find solutions. Demonstrated computer literacy and functional knowledge of Microsoft packages. Working Conditions Home based, with the ability to go into the office when needed. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us. #J-18808-Ljbffr

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