Medical Monitor

Medical Monitor role based in Taipei within PSI's Medical Monitoring team. Responsibilities include advising clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters; collaborating with internal teams to prepare clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and scientific presentations; reviewing and analyzing clinical data to ensure participant safety and trial compliance with approved protocol/ICH-GCP; addressing safety issues across the study from sites and the study team; participating in bid defense meetings; assisting in pharmacovigilance activities; identifying program risks and implementing mitigation strategies with Clinical Operations; organizing and leading clinical development advisory boards and safety monitoring boards; ensuring study team compliance with local regulatory agencies; reviewing and signing off clinical documents for medical relevance; the role requires a Medical Doctor degree with desirable board-certification in major therapeutic areas and prior clinical research experience; ability to interact with and train clinical monitors and physician investigators; strong communication, leadership, and organizational skills; proficiency with MS Office. At PSI, you will join an international group of medical professionals focused on advancing clinical research and bringing new medications to patients.