Clinical eTMF Inspection Readiness: Functional Quality Check (FQC) Program Leadership

I led and operationalized a Functional Quality Check (FQC) program focused on clinical eTMF completeness and inspection readiness. The original aspect of my work was building a practical, repeatable execution model that combined hands-on quality review with standardized workflows and training so that FQC could be delivered consistently across a large, multi-study environment. In addition to completing FQCs, I identified gaps in existing processes and training and authored documentation to standardize how FQC work is performed. This enabled faster, more reliable detection and correction of missing documentation in the eTMF and strengthened readiness for regulatory inspection activities.