Alimentiv
[BR] TMF Associate at Alimentiv
Role overview
An at-a-glance view of the facts included with this [BR] TMF Associate at Alimentiv listing.
- Company
- Alimentiv
- Location
- Brazil, Canada, Hungary, Poland, Romania, UK
- Work arrangement
- Remote
- Employment type
- Full-time
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Role overview
This job description has been rewritten in fresh language using the facts in the listing. Source credit and original listing details are available below.
Alimentiv is hiring two full-time, permanent TMF Associates for remote, home-based work in Brazil, Canada, Hungary, Poland, Romania, or the UK. The role reports to the Manager, TMF Operations and supports Trial Master File activities from study setup through transfer or archival. Occasional office attendance may be needed.
Role at a glance: Manage and oversee Trial Master File content and processes throughout the study lifecycle in a remote, full-time role.
Responsibilities mentioned in the listing
- Act as the primary TMF contact for assigned studies and help keep files complete, current, and ready for inspection.
- Partner with the Team Lead to prepare study-specific TMF oversight materials, such as file indexes, expected document lists, and management plans.
- Create and maintain study-specific work instructions when required, and reconcile expected documents against study events and milestones.
- Schedule and conduct periodic TMF inventories and quality checks; communicate incomplete or out-of-scope documents to study teams and escalate issues as needed.
- Prioritize and resolve TMF help desk requests, including triage when appropriate.
- Provide TMF training to internal or external stakeholders as needed.
- Process, review, file, and retrieve documents promptly, following applicable scanning practices and ALCOA principles.
Qualifications stated in the listing
- College diploma or degree, plus 1–3 years of relevant experience or ongoing training.
- Understanding of TMF organization, implementation, and archival, including relevant regulations and guidance for TMF quality and integrity.
- Ability to apply ALCOA principles to TMF oversight.
- Time-management and problem-solving skills, including initiative in identifying challenges and solutions.
- Computer literacy and working knowledge of Microsoft applications, with the ability to develop further.
Full details from the source listing
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.
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 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 on going 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 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.
Working Conditions
- - Home based, with the ability to go into office occasionally if needed.
- *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 [email protected]
Warning
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