Sr TMF Reviewer - FSP

Role Summary

Sr TMF Reviewer - FSP role focusing on TMF/eTMF management for sponsored clinical studies, ensuring completeness, accuracy, and inspection readiness in line with ICH/GCP guidelines. Remote US availability.

Responsibilities

• Manage TMF/eTMF review of electronic Trial Master Files (eTMF), including trial, country, and site artifacts for clinical studies.
• Provide process, control, coordination, and approval of clinical trial documents.
• Maintain understanding of applicable regulatory requirements.
• Operate TMF processes for electronic files across study phases, collaborating with study personnel.
• Perform TMF reviews with involvement from Project Team members, Global Quality Control, and other reviewers.
• Map sponsors TMF Index with respect to Fortrea UCV and TMF Review as applicable.
• Maintain audit readiness of TMF for quality and compliance; conduct Audit Ready Checks on documents.
• Initiate What's Missing to ensure full TMF completeness, tracking artifacts against the TMF Plan and Index and study milestones.
• Adhere to performance metrics for TMF reviews; track final artifacts per Fortrea and sponsor SOPs, GCP, and ICH guidelines.
• Identify operational issues and resolutions related to the TMF; gather data to support client status reports.
• Prepare TMF for QA or sponsor audits and implement corrective actions for audit findings.
• Participate in client audits and regulatory inspections; respond to TMF content quality issues and identify trends.
• Collaborate with BP and S teams; ensure client satisfaction across studies.
• Participate in business improvement initiatives to drive quality and process efficiency.
• Attend internal or external study team meetings; perform support activities and training as required; maintain direct client contact as needed.

Qualifications

• Bachelor‚Äôs Degree with a Life Sciences/Business focus (or equivalent experience).
• Excellent interpersonal skills.

Experience

• Minimum 6 years experience in a clinical research environment.
• 5+ years of experience with electronic records management systems, managing active, inactive, and archived records; analyzing business processes and developing Records Management policies.
• Clear understanding of GCP and ICH guidelines; knowledge of Regulatory/Clinical document requirements.
• Proficiency with Microsoft Office, web-based applications, Adobe Acrobat Standard; ability to apply scanning and related software.

Preferred Qualifications

• BS/BA degree in related discipline with 5+ years of related experience, or
• MS/MA degree with 3+ years of related experience, or
• Equivalent combination of education and experience.

Education

• Bachelor‚Äôs Degree in Life Sciences/Business or related field preferred.

Additional Requirements

• Physical requirements include siting for extended periods and occasional lifting up to 15-20 lbs; standard office environment.
• Travel as required by role; varied hours may be required.