Sr TMF Reviewer - FSP

Role Summary

Sr. TMF Reviewer - FSP for Fortrea's FSP Team. This remote-US role focuses on TMF and eTMF management for all sponsored studies, ensuring the completeness and accuracy of the Trial Master File throughout the trial lifecycle and supporting inspection readiness in compliance with ICH/GCP guidelines. The role acts as the TMF subject matter expert across research phases and collaborates cross-functionally to support study teams.

Responsibilities

• Provide process, control, coordination, and approval of clinical trial documents.
• Responsible for ECD, Phase I–IV electronic trial master file (eTMF).
• Maintain an understanding of applicable regulatory requirements.
• Manage 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, 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).
• Maintain 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.
• Manage 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.
• Attends internal or external study team meetings as required.
• Performs support activities as required.
• Performs training as required.
• Direct contact with Client as required.
• All other duties as needed or assigned.

Qualifications

• Required: Bachelor’s Degree with a Life Sciences/Business focus. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Required: Excellent interpersonal skills.
• Required: Minimum 6 years’ experience working in a clinical research environment.
• Required: 5+ years 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.
• Required: Clear understanding of GCP and ICH guidelines.
• Required: Knowledge of Regulatory/Clinical document requirements.
• Required: 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: 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.

Education

• Bachelor’s Degree in Life Sciences or Business (or related field).

Skills

• TMF/eTMF management and archival processes
• Documentation control, audit readiness, and TMF quality assurance
• Regulatory knowledge: GCP and ICH guidelines; regulatory/clinical document requirements
• Cross-functional collaboration and strong interpersonal skills
• Proficiency with Microsoft Office, web-based applications, and Adobe Acrobat