Tmf Reviewer Ii

4 days ago

Bengaluru, India Fortrea Full time

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 document classification, ARC review, (when applicable)
- 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) and responsible for performing QC into Sponsor system (TMF Classifier) if applicable.
- 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 Labcorp 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&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 other related duties as assigned.
- Perform Training & Mentoring as required.

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