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.

Qualifications

• 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.

Why Vericel?

• Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
• Career Growth: Be a part of a growing organization with opportunities to expand your impact.
• Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.

The salary range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $75,000 to $95,000 annually.

The actual salary offered will be determined based on factors such as the candidate’s qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above.

In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited.

EEO Statement

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.