TMF Associate
TMF Associate
Posted on :
17-03-2025
Employer Active
1 Vacancy
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Job Description
Job Title:TMF Associate
Job Location:Toronto ON (remote)
Job Salary:$52500 $87500 CAD
Employment Type:Full time Limited Term (March 2025 May 2026
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 setup to transfer/archiving. Work in partnership with study teams during periodic file reviews and audits to address findings related to theTMF. Manage access and organization of the controlled electronic file repository in line with the defined file structure and accessmanagement framework. Work proactively and successfully within a crossfunctional team. Communicate and promote department andcompany goals and practices. Interact with stakeholders in a way that fosters a positive working atmosphere and encompasses aprofessional and helpful attitude. Time allocated may be adjusted based on need.
Service Delivery
- Serveas the primary TMF contact for assigned studies.
- Ensure TMF is completeand inspection ready throughout study lifecycle and documents are filed contemporaneously.
- Work with Team Leadto 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 maintainstudyspecific work instructions as needed.
- Utilizeorganization skills to maintain a quality control schedule and perform periodic inventories of study TMF to ensure completeness.
- Review andcommunicate outofscope and/or incomplete documents to study teams; escalating as needed.
- Reconcile expecteddocument lists based on study events and milestones.
- Prioritizeand resolve TMF help desk tickets; may include triaging activities.
- Provide study specificTMF training to internal and/or external stakeholders as needed.
- Process andreview documents following applicable scanning and best practices and bestpractices and applying ALCOA principles appropriately.
- Fileand 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 13 years of relative related experience or ongoing training. They will have an understanding of TMF organization implementation and archival including relevant regulations and guidance to assure quality and integrity of TMFs. Have the ability to incorporate the principles of ALCOA in relation to TMF oversight. Utilize skills in time management and problemsolving. Identify challenges and problems and take the initiative to identify solutions. Demonstrated computer literacy proven functional knowledge of Microsoft packages and potential to develop.
$52500 $87500 a year
PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams leveraging various methods of attack via email text voice and social media. Please note that Alimentiv only uses company email addresses which contain @alimentiv to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv please verify the domain of the senders email address and that they are asking you to apply on this website. If you believe youve been a victim of a phishing scam please contact your local government cyber authority to report.
*Accommodations are available for applicants with disabilities upon request throughout the recruitment lifecycle
Required Experience:
IC
Employment Type
Full-Time
Key Skills
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