Base pay rangeCA$52,500.00/yr - CA$87,500.00/yrResponsible for the management of the Trial Master File (TMF) content and associated processes during the study life cycle from study setup 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 skilled and helpful attitude. Time allocated may be adjusted based on need.Service DeliveryServe as the primary TMF contact for assigned studiesEnsure TMF is complete and “inspection ready” throughout study lifecycle and documents are filed contemporaneouslyWork 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 studyDevelop and maintain study‑specific work instructions, as neededUtilize organization skills to maintain a quality control schedule and perform periodic inventories of study TMF to ensure completenessReview and communicate out‑of‑scope and/or incomplete documents to study teams; escalating as neededReconcile expected document lists based on study events and milestonesPrioritize and resolve TMF help desk tickets; may include triaging activitiesProvide study specific TMF training to internal and/or external stakeholders, as neededProcess and review documents,



following applicable scanning and best practices and applying ALCOA principles appropriatelyFile and retrieve TMF documents in a timely mannerDepartment SupportComplete 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 groupsSeek 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 staffPropose suggestions and work on the development and maintenance of department quality system documents to improve efficienciesQualificationsThe successful candidate will possess a college diploma/degree and 1‑3 years of relative related experience or ongoing trainingA 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 skillsWorking ConditionsHome based, with the ability to go into 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.Seniority levelNot ApplicableEmployment typeFull‑timeJob functionOtherIndustriesPharmaceutical Manufacturing#J-18808-Ljbffr

📌 Tmf Associate - C$52,500 - C$87,500 A Year (Winnipeg)
🏢 Alimentiv
📍 Winnipeg