Base pay range
CA$52,500.00/yr - CA$87,500.00/yr

Responsible 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 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 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 1‑3 years of relative related experience or ongoing training

A robust 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 skills

Working Conditions

Home 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 level

Not Applicable

Employment type

Full‑time

Job function

Other

Industries

Pharmaceutical Manufacturing

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📌 TMF Associate (Quebec City)
🏢 Alimentiv
📍 Quebec City