Medical Monitor – Gastroenterology (Taipei)

About the role

PSI, a leading Contract Research Organization, is seeking a Medical Monitor specialized in Gastroenterology to join its international Medical Monitoring team in Taipei. You will work on the front line of clinical science, ensuring patient safety and supporting the development of new therapies.

Key responsibilities

• Advise clients, project teams, sites, DSMBs, regulatory agencies and vendors on medical matters.
• Collaborate on clinical development plans, protocols, investigator brochures, reports and scientific presentations.
• Review and analyse clinical data to ensure participant safety and trial compliance.
• Address safety issues, support pharmacovigilance activities and participate in bid defense meetings.
• Identify program risks, develop mitigation strategies and lead advisory and safety monitoring boards.
• Ensure compliance with local regulatory requirements, ICH and GCP guidelines, and sign‑off on medical documents.

Required profile

• Medical Doctor degree; board‑certification in Gastroenterology preferred.
• Clinical experience in therapeutic areas such as Oncology, Infectious Disease, Gastroenterology, Hematology or Internal Medicine.
• Prior experience in clinical research and familiarity with local health‑authority processes.
• Ability to train clinical monitors and physician investigators and build constructive relationships.

Required skills

• Pharmacovigilance
• ICH guidelines
• Good Clinical Practice (GCP)