Remote TMF Operations Specialist

Alimentiv; United States; Remote; 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

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.