Tmf Associate - Toronto, Canada - Alimentiv
Description
Job Title:
TMF Associate
Job Location:
London, ON
Job Salary:
$50,000 - $84,000 CAD
Employment Type:
Full time, Limited Term (18-month contract)
Job Reports To:
Manager, TMF Operations
Department/Unit Name:
TMF Operations
Job Summary:
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.
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.Areas of Responsibility:
- 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 studyspecific 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 outofscope 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:
- Home based, with the ability to go into office occasionally if needed.
More jobs from Alimentiv
-
Clinical Project Manager
Toronto, Canada - 5 days ago
-
Medical Monitor
Montréal, Canada - 2 days ago
-
Scientific Marketing Content Associate
Remote, Canada - 2 days ago
-
Administrative Generalist
London, Canada - 1 week ago
-
Clinical Project Coordinator
London, Canada - 1 week ago
-
Legal Counsel
Toronto, Canada - 1 week ago