Scan your resume against ATS criteria for this TMF Associate role at Alimentiv 2.
Job Title: TMF Associate
Employment Type: Full time, Permanent
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. 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.
Positions Available: 2; Note this position is cross-listed in multiple countries.
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 best practices, and applying ALCOA principles appropriately.
File and retrieve TMF documents in a timely manner.
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.
*Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to mailto:[email protected] [email protected]
How to apply for TMF Associate at Alimentiv 2?
Click the "Apply on Company Website" button on this page to submit your application directly on the employer's official portal.
What is the salary for this role?
Salary details will be discussed during the interview.
What experience is required?
1-3 years of experience is required.
Is this position still open?
Yes, currently active and accepting applications.
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TMF Associate
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