Debendra Koirala

Led operational medical monitoring for global oncology and non-oncology clinical trials, ensuring GCP, protocol, and regulatory compliance. Reviewed safety data, adverse events, and narratives, and supported clinical data review and database lock activities.

Served as Medical Monitor for a rare disease program, providing medical input for risk assessment and patient safety. Led planning and execution of a critical-path Phase 2 trial and established the Global Scientific Advisory Board and Safety Monitoring Committee.

Conducted medical review of over 2,000 ICSRs for EUA COVID-19 vaccine and oncology studies, assessing causality and expedited reporting. Performed signal detection and authored safety reports including DSURs and Risk Management Plans.

Led Merck's Breast Oncology Clinical Development Program as Medical Monitoring Subject Matter Expert, directing trial design and scientific execution. Reviewed SAEs and supported safety surveillance and committee activities.

Provided medical monitoring oversight of site eligibility and safety data across therapeutic areas. Performed clinical data review and supported protocol amendments and safety plan sign-offs.

Provided medical oversight and endpoint adjudication for global Phase I-III trials, supporting SAE review and signal detection. Contributed to Clinical Events Committee start-up and management.

Triaged and medically reviewed ICSRs across Phase I-IV and post-marketing surveillance. Authored safety narratives and maintained safety database quality.

Provided certified medical interpretation services across clinical care settings.

Managed outpatient and urgent care services and a 15+ person staff. Led a Hepatitis-B immunization campaign across Nepal schools.

Assisted major and minor reconstructive surgeries and was active in medical research.

Performed major and minor surgeries and supported medical research per international guidelines.

Master of Public Health (MPH) and Post Graduate Diploma in Public Health from the University of Wolverhampton.

Doctor of Medicine (MD) degree from St. Petersburg State Pediatric Medical University.