Medical Monitor (Gastroenterology)

About the role

PSI is seeking a Medical Monitor specialized in Gastroenterology to join its international Medical Monitoring team in Hong Kong. You will work on the front line of clinical research, ensuring patient safety and data integrity while supporting the development of new therapies.

Key responsibilities

• Advise clients, project teams, sites, DSMBs, regulatory agencies and 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 raised by sites and study teams.
• Participate in bid defense meetings and assist in pharmacovigilance activities.
• Identify program risks and implement mitigation strategies with Clinical Operations.
• Organise and lead clinical development advisory boards and safety monitoring boards.
• Ensure study team compliance with local regulatory agencies, ICH and GCP guidelines.
• Review 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.
• Full proficiency in English (written and spoken).
• Prior experience in clinical research and familiarity with local health‑authority interactions.

Required skills