Tmf Associate

2 weeks ago

London, Canada Alimentiv Full time

Responsible for the management of the Trial Master File (TMF) content and associated processes during the study life cycle from study set up 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.
- 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**:
**Working Conditions**:

- Hybrid-based

+ Bonus

  • TMF Associate

    1 week ago

    London, Ontario, Canada Alimentiv Full time $52,500 - $87,500 per year

    Responsible for the management of the Trial Master File (TMF) content and associated processes during the study life cycle from study set up 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...

  • TMF Associate

    3 days ago

    London, Ontario / Toronto, Ontario / Kitchener, Ontario, Canada Alimentiv Full time $52,500 - $87,900 per year

    Responsible for the management of the Trial Master File (TMF) content and associated processes during the study life cycle from study set up 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,...

  • TMF Manager

    4 weeks ago

    London, Canada Alimentiv Full time

    TMF Manager – Overview The TMF Manager provides advanced leadership in Trial Master File (TMF) strategy and operations, independently guiding complex studies and ensuring excellence in TMF management. This role serves as a key escalation and decision‑making point between study teams and TMF Operations, driving alignment and timely resolution. The TMF...

  • Remote TMF Associate

    1 week ago

    Toronto, Montreal, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Surrey, Victoria, London, Halton Hills, Regina, Markham, Brampton, Vaughan, Kelowna, Laval, Southwestern Ontario, R, Canada Alimentiv Inc. Full time

    A healthcare solutions company located in Toronto is seeking a professional to manage the Trial Master File (TMF) throughout the study lifecycle. The role requires strong organizational skills and a solid understanding of TMF principles, with responsibilities including document management and stakeholder communication. The position offers a salary range of...

  • Remote TMF Associate

    1 week ago

    Kitchener, Toronto, Montreal, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Surrey, Victoria, London, Halton Hills, Regina, Markham, Brampton, Vaughan, Kelowna, Laval, Southwestern, Canada Medium Full time

    A healthcare company is seeking a TMF Manager to oversee the Trial Master File throughout the study lifecycle. This role involves ensuring the TMF is complete and inspection-ready, managing documentation effectively, and providing mentorship to junior staff. The ideal candidate will have a college diploma and relevant experience along with strong...

  • Remote TMF Associate

    1 week ago

    Toronto, Montreal, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Surrey, Victoria, London, Halton Hills, Regina, Markham, Brampton, Vaughan, Kelowna, Laval, Southwestern Ontario, R, Canada Medium Full time

    A leading company in clinical management seeks a TMF Manager to oversee the Trial Master File content and processes. Responsibilities include ensuring the TMF is complete and ready for inspection, providing training, and managing documents throughout the study lifecycle. The ideal candidate has a college degree and relevant experience, alongside skills in...

  • Clinical Operations Lead

    3 days ago

    London, Canada Alimentiv Full time

    Responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations. The COL acts as a primary liaison...

  • Lead Clinical Research Associate

    3 weeks ago

    Toronto, Montreal, Calgary, Vancouver, Edmonton, Old Toronto, Ottawa, Mississauga, Quebec, Winnipeg, Halifax, Saskatoon, Burnaby, Hamilton, Victoria, Surrey, Halton Hills, London, Regina, Markham, Brampton, Vaughan, Kelowna, Laval, Southwestern Ontario, R, Canada PSI CRO Full time

    PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.Job DescriptionCoordinates investigator/ site feasibility and identification process, as...