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 Singapore. You will work on the front line of clinical science, ensuring the safety and integrity of clinical trials while supporting the development of new medicines.

Key responsibilities

• Advise clients, project teams, sites, DSMBs, regulatory agencies and vendors on medical matters.
• Collaborate on clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts and scientific presentations.
• Review and analyse clinical data to safeguard study participants and ensure compliance with approved protocols.
• Address safety issues, participate in bid defense meetings and support pharmacovigilance activities.
• Identify program risks, develop mitigation strategies and lead clinical development advisory and safety monitoring boards.
• Ensure study team compliance with local regulatory agencies, ICH and GCP guidelines and sign‑off on 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.
• Prior experience in clinical research and interaction with health authorities for drug approval.
• Ability to train and collaborate with clinical monitors and physician investigators.

Required skills

• Pharmacovigilance
• Clinical research methodology
• ICH guidelines
• GCP guidelines
• Medical data review and safety monitoring