Sr. TMF Reviewer

Responsibilities

• Process and track final essential artifacts required throughout all phases of the study in accordance with Fortrea SOPs, sponsor SOPs, GCP and ICH guidelines.
• Review and respond to TMF content quality issues and identifies trends per study and across programs; alerts management of trends.
• Perform support activities as required.
• Perform Training as required.
• Position provides process, control, coordination, and approval of clinical trial documents.

Requirements

• 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
• 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.
• 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 working in a clinical research environment.
• 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: Masters’s Degree with a Life Sciences/Business focus. Equivalent
• experience within clinical research environment of a minimum of 8 to 10 years, may be substituted for education requirements.
• Experience working in clinical electronic systems preferred.

Additional details