Medical Monitor – Gastroenterology

About the role

PSI, a global Contract Research Organization, is seeking a Medical Monitor specialized in Gastroenterology to join its Medical Monitoring team in Taipei. This full‑time position offers the opportunity to work on international clinical trials, ensuring patient safety and data integrity while supporting the development of new therapies.

Key responsibilities

• Advise clients, project teams, sites, DSMBs, regulatory agencies and third‑party vendors on medical matters.
• Collaborate with internal departments to prepare clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts and scientific presentations.
• Review and analyse clinical data to ensure participant safety and compliance with approved protocols.
• Address safety issues, participate in bid defense meetings and assist in pharmacovigilance activities.
• Identify program risks, develop mitigation strategies and lead clinical development advisory boards and safety monitoring boards.
• Ensure study team compliance with local regulatory agencies, ICH and GCP guidelines and sign off clinical documents for medical relevance.

Required profile

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

Required skills