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Fortrea's FSP Team is hiring a Sr. TMF Reviewer! Remote US

TMF Management is responsible for the completeness and accuracy of the Trial Master File for all sponsored studies. Deliver technical expertise in the Trial Master File (TMF) and electronic TMF (eTMF). Provide support for the book of work for all sponsored clinical trials throughout the lifecycle of the trial and support inspection readiness goals in compliance with ICH/GCP guidelines.

Key deliverables include monitoring and assessing the overall health of the TMF, ensuring quality, completeness and timeliness in the eTMF for all sponsored studies, working closely with the study teams. Subject Matter Expert for eTMF, spans across all research phases, collaborates cross-functionally throughout the lifecycle of the trials.

Job Overview:

Manages ARC review and are responsible for performing TMF review of electronic Trial Master Files (eTMF), Trial, Country, and Site artifacts for clinical studies in support of sponsors services contracts and internal business needs.

Summary of Responsibilities:

• Position provides process, control, coordination, and approval of clinical trial documents.
• Position is responsible for ECD, Phase I-IV electronic trial master file (eTMF).
• Maintains an understanding of applicable regulatory requirements.
• Managing electronic Trial Master Files (eTMF), (Trial, Country, and Site artifacts) for clinical studies in accordance with TMF processes, working with key study personnel such as the Study Team Member.
• Responsible for performing TMF review. TMF Reviewers may include, but are not limited to, Project Team members, members of Global Quality Control and other reviewers (e.g. Central TMF Reviewers).
• Responsible for mapping the sponsors TMF Index with respect to Fortrea UCV and TMF Review, if applicable (TMF Reviewers).
• Maintains the TMF in a state of audit readiness for quality and compliance by:
• Performing Audit Ready Checks on individual documents uploaded in the eTMF system for every study, ensuring context is accurate.
• Initiating the What’s Missing for all documents and ensuring full completeness of the TMF for each study, tracking and obtaining missing, incomplete, incorrect, inaccurate artifacts against the TMF Plan and Index, and study milestones.
• Comply with metrics established for performance TMF reviews.
• Process and track final essential artifacts required throughout all phases of the study in accordance with Fortrea SOPs, sponsor SOPs, GCP and ICH guidelines.
• Manages the identification of operational issues and resolutions related to the TMF.
• Responsible for gathering data requested by study team to support status reports to clients.
• Prepares the TMF for QA or Sponsor audits, the resolution with identifying and implementing corrective actions to findings in audit reports.
• Participates in client audits and regulatory inspections.
• Review and respond to TMF content quality issues and identifies trends per study and across programs; alerts management of trends.
• Collaborates with all members of BP and S.
• Ensures overall client satisfaction for all studies.
• Participates in business improvement initiatives to drive quality, productivity, and continuous improvement of business processes.
• Maintains an understanding of applicable regulatory requirements.
• Attend internal or external study team meetings as required.
• Perform support activities as required.
• Perform Training as required.
• Direct contact with Client as required.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• Bachelor’s Degree with a Life Sciences/Business focus.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Excellent interpersonal skills.

Experience (Minimum Required):

• Minimum 6’ experience working in a clinical research environment.
• 5+ years in experience using electronic records management systems, with progressive experience managing active, inactive, and archived records, analyzing business processes, and developing and implementing Records Management policy and procedures
• Clear understanding of GCP and ICH guidelines.
• Knowledge of Regulatory/Clinical document requirements.
• Knowledge of Microsoft Office products, web-based applications, and Adobe Acrobat Standard, plus the ability to apply related knowledge regarding scanning and other software programs.

Preferred Qualifications Include:

• BS/BA degree in related discipline and a minimum of five years of related experience; or,
• MS/MA degree in related discipline and a minimum of three years of related experience; or,
• Equivalent combination of education and experience.

What do you get?

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:

• Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)

• 401(K)

• Paid time off (PTO) – Flex Plan

• Employee recognition awards

• Multiple ERG’s (employee resource groups)

• Target Pay Range (based on title): $90-106K

#LI - Remote

Applications will be accepted on an ongoing basis.

Work Environment:

• Work is performed in an office environment with exposure to electrical office equipment.

Physical Requirements:

• Ability to sit for extended periods and operate a vehicle safely.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Regular and consistent attendance.

• Varied hours may be required.

Learn more about our EEO & Accommodations request here.