Michelle Orlere

Led full-cycle monitoring across 8–12 active sites for Phase II–III oncology and CNS trials, executing ICH-GCP and FDA-compliant risk-based monitoring. Reduced unnecessary SDV effort by 20% while maintaining >98% data accuracy, lowered repeat deviations by 25%, and maintained inspection-ready eTMF documentation with zero critical audit findings.

Managed 5–8 clinical sites simultaneously across Phase I–III trials, conducting IMVs and remote monitoring to ensure protocol compliance and accurate EDC data capture. Reduced startup delays by 15%, improved enrollment rates by 18%, cut query resolution time by 25%, and supported SAE/SUSAR reconciliation for timely safety reporting.

Supported global clinical trials through remote monitoring and site management assistance, helping ensure consistent compliance across regions. Improved data accuracy and consistency via EDC data review and query resolution tracking, maintained eTMF completeness, and ensured protocol deviations and CAPAs were documented with timely closure.

Provided operational and documentation support across Phase I–IV clinical trials by maintaining TMF/eTMF to keep essential documents complete, current, and inspection-ready. Assisted with monitoring visit preparation and trip report follow-ups, coordinated investigator queries, and supported enrollment tracking while adhering to ICH-GCP and sponsor SOPs.

Pursuing a Master’s in Healthcare Administration at the University of North Texas Health Science Center (Jun 2025–Jul 2027).

Earned a Bachelor of Science in Applied & Environmental Biology from Rivers State University (Jan 2007–Nov 2011).