Medical Monitor – Gastroenterology

About the role

PSI is seeking a Medical Monitor specialized in Gastroenterology to join its Medical Monitoring team in Singapore. The role involves overseeing the safety and scientific integrity of clinical studies, collaborating with internal and external stakeholders, and contributing to 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 protocol compliance.
• Address safety issues, support pharmacovigilance activities and manage risk mitigation strategies.
• Organise and lead advisory boards and safety monitoring boards.
• Ensure compliance with local regulatory agencies, ICH and GCP guidelines.
• Participate in bid defense meetings 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.
• Ability to train and interact with clinical monitors and physician investigators.

Required skills

• Pharmacovigilance.
• Clinical data review.
• Regulatory compliance (ICH, GCP).