Medical Monitor

Medical Monitor role based in Hong Kong within a global CRO, focusing on frontline medical oversight of clinical trials. Responsibilities include advising clients, project teams, DSMBs, regulatory bodies, and vendors on medical matters; collaborating on clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and scientific presentations; reviewing clinical data to ensure participant safety and compliance with approved protocols and ICH/GCP guidelines; addressing safety issues across studies; participating in bid defense meetings; assisting pharmacovigilance activities; identifying program risks and implementing mitigation strategies with Clinical Operations; organizing and leading clinical development advisory boards and safety monitoring boards; ensuring regulatory interactions and study team compliance; reviewing and signing off medical relevance of clinical documents; strong leadership, communication, and organizational skills; proficiency with MS Office; requires Medical Doctor degree with desirable board-certification in Oncology, Infectious Disease, Gastroenterology, Hematology, or Internal Medicine.