Job
Description
As a TMF Reviewer at Fortrea, your role involves 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 Fortrea business needs. Key Responsibilities: - Provide process, control, coordination, and approval of clinical trial documents. - Manage 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, collaborating with key study personnel such as the Study Team Member. - Perform document classification, ARC review (when applicable). - Conduct TMF review including mapping the sponsors TMF Index with respect to Fortrea UCV and TMF Review, if applicable. - Maintain the TMF in a state of audit readiness by performing Audit Ready Checks, initiating the What's Missing process, and ensuring full completeness of the TMF for each study. - Comply with established metrics 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. - Gather data requested by study team to support status reports to clients. - Prepare the TMF for QA or Sponsor audits, and implement corrective actions to findings in audit reports. - Participate in client audits and regulatory inspections. - Review and respond to TMF content quality issues, identify trends per study and across programs, and alert management of trends. - Collaborate with all members of BP and S to ensure overall client satisfaction for all studies. - Participate in business improvement initiatives to drive quality, productivity, and continuous improvement of business processes. - Attend internal or external study team meetings as required. - Perform any other duties as needed or assigned. Qualifications: - Bachelors Degree with a Life Sciences/Business focus. - Relevant and equivalent experience may be considered in lieu of educational requirements. - Excellent interpersonal skills. Experience: - Minimum 6 to 10 years of experience working in a clinical research environment. - Clear understanding of GCP and ICH guidelines. - Knowledge of Regulatory/Clinical document requirements. - Proficiency in Microsoft Office products, web-based applications, and Adobe Acrobat Standard. Preferred Qualifications: - Masters Degree with a Life Sciences/Business focus. - Equivalent experience within clinical research environment of a minimum of 6 to 10 years may be substituted for education requirements. - Experience working in clinical electronic systems preferred.,
