Medical Monitor – Gastroenterology

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 Hong Kong. You will work on the front line of clinical science, ensuring patient safety and data integrity across clinical studies.

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 safeguard study participants and ensure compliance with protocols.
• Address safety issues, participate in bid defenses and support pharmacovigilance activities.
• Identify program risks, develop mitigation strategies and lead advisory and safety monitoring boards.
• Ensure compliance with local regulatory agencies, ICH and GCP guidelines and sign off 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.
• Full proficiency in written and spoken English.
• Prior experience in clinical research and familiarity with local health‑authority interactions.

Required skills

• Clinical Research
• Pharmacovigilance
• Medical Monitoring