The eTMF Lead, in compliance with the applicable procedures, is mainly responsible for the eTMF management, as Process... both eTMF Assistant and eTMF Specialist on documentation management and archiving procedures to ensure high documents quality...
documents in partnership with CTM, CRAs and TMF Lead as applicable. Data & System Management: Support subject tracking, data... entry oversight, and system maintenance in CTMS and eTMF; assist with eCRF UAT testing and clinical sample tracking...
. Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration... metrics. Ensures audit readiness at site level. Acts in the project role of a Lead CRA as assigned. General On-Site Monitoring...