At IQVIA, I conduct on-site and remote monitoring visits and manage clinical vendor deliverables, supporting compliance with sponsor SOPs, FDA regulations, and ICH/GCP guidelines.
At Johns Hopkins Medicine, I coordinated operations across 30+ active Phase I-III oncology trials. I maintained eTMF and regulatory binder quality, coordinated site initiation visits, and tracked vendor performance and study risks.
At Novartis, I assessed assay variability for CAR-T cell therapy products and assisted with FDA audit preparations and regulatory submissions.
At the Federal Ministry of Health (FMOH), I coordinated Phase I-IV trials across multiple sites and collaborated on an oncology clinical trial program across three academic institutions. At the National Biotechnology Development Agency (NABDA), I authored SOPs and co-developed a work plan for recombinant vaccine laboratory operations.
