Medical Monitor – Gastroenterology

About the role

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

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 and participate in bid‑defense meetings.
• Assist in pharmacovigilance activities and identify program risks, implementing 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 and sign off clinical documents for medical relevance.

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 interactions leading to drug approval.
• Ability to interact with and train clinical monitors and physician investigators, building constructive relationships at all levels.

Required skills

• Pharmacovigilance
• Medical monitoring
• Clinical data review
• Regulatory compliance (ICH, GCP)
• Medical writing