TMF Specialist

Vericel Corporation•Burlington, MA

1d•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in life sciences, healthcare, or related field.
Minimum 2+ years in clinical research and documentation management, preferably in research or healthcare setting.
Strong understanding of regulatory requirements and guidelines governing clinical trial documentation (e.g., ICH-GCP, FDA regulations).
Experience with eTMF systems and software applications (e.g., Microsoft Office, electronic data capture systems).
Excellent communication skills with the ability to effectively collaborate with diverse stakeholders and convey complex information clearly and concisely.
Exposure to audit/inspection readiness activities.
Ability to manage multiple studies and priorities.

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.