TMF Associate

Alimentiv; United States; On-site; USD 60,000 - 100,000; Full time

Job summary

Alimentiv in the United States seeks a TMF Associate to manage TMF content across study life cycles. You will maintain repository structure, ensure inspection readiness, and support audits with cross-functional teams.

Responsibilities include TMF training, document reconciliation, and timely filing while applying ALCOA principles. Home-based with occasional office visits, this role reports to Manager, TMF Operations.

Qualifications

• Candidate will possess a college diploma/degree and 1-3 years of related TMF experience.
• Demonstrated understanding of TMF organization, implementation, and archival including relevant regulations and guidance to assure quality and integrity of TMFs.

Responsibilities

• Serve as the primary TMF contact for assigned studies.
• Ensure TMF is complete and “inspection ready” throughout study lifecycle and documents are filed contemporaneously.
• Create study-specific TMF management documents in alignment with study.
• Develop and maintain study-specific work instructions as needed.
• Maintain a quality control schedule and perform periodic TMF inventories.
• Review and communicate out-of-scope or incomplete documents to study teams; escalate as needed.
• Reconcile expected document lists based on study events and milestones.
• Prioritize and resolve TMF help desk tickets; triage activities as needed.
• Provide TMF training to internal and external stakeholders as needed.
• Process and review documents following scanning and ALCOA principles.
• File and retrieve TMF documents in a timely manner.
• Complete routine department tasks (timesheets, metrics).
• Participate in department meetings and knowledge sharing.

Skills

Time management

Problem solving

Communication

Education

College diploma/degree

Tools

Microsoft Office

Job description

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 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 cross-functional 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.

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 [e-mail]