TMF Specialist

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).

Position Summary

The TMF specialist is responsible for the end-to-end management, quality, and integrity of clinical trial documentation. This role ensures a "continuous state of readiness" for regulatory inspections by overseeing the lifecycle of essential records across multiple clinical systems.

Schedule

This position is in-office from Monday – Thursday in our new Burlington, MA location, with flexibility to work remotely on Fridays.

• Key Responsibilities
• Develops and updates TMF plans and indexes; conducts rigorous quality control (QC) of incoming records; maintains detailed TMF metrics and reports and ensures timely filing of essential records for all assigned centers.
• Tracks and reports on key study metrics - including regulatory package status, TMF completeness, and site statuses - providing regular updates to leadership and escalating issues with proposed mitigation strategies.
• Proactively identifies and resolves TMF gaps by partnering with internal teams, clinical sites, IRBs and Contract Research Organizations (CROs) to resolve documentation discrepancies.
• Participates in inspection readiness by conducting internal reviews, organizing essential records, and participates in mock audits to ensure a "continuous state of readiness."
• Supports Clinical Research Associates (CRAs) for monitoring visits and performs eISF (electronic Investigator Site File) reviews and provides TMF vs ISF reconciliation reports.
• Manages Institutional Review Board (IRB) approvals for Humanitarian Use Devices (HUD) through consistent facility communication and the maintains of cross-functional IRB trackers.
• Maintains and support clinical systems such as CTMS eTMF and Smartsheet, ensuring metrics and accuracy.
• Contributes to departmental improvements, including the authorship of SOPs (Standard Operating Procedures) of study templates and tools and contributes to the optimization of processes within the department.
• Lead study meeting activities, including preparing agendas, facilitating discussions, and documenting key decisions and action items.
• Perform other tasks assigned to support evolving clinical trial needs and departmental goals.