Medical Monitor – Gastroenterology

About the role

As a member of PSI’s Medical Monitoring team, you will work at the front line of medical science, providing expert oversight for gastro‑enterology clinical studies. You will collaborate with international project teams, study sites and sponsors to ensure patient safety and the delivery of high‑quality trial data.

Key responsibilities

• Serve as the medical point of contact for internal teams, study sites and sponsors on protocol‑driven clinical trials.
• Advise clients, regulatory agencies and third‑party vendors on medical matters and GCP compliance.
• Contribute to the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, patient narratives and scientific presentations.
• Review and analyse clinical data to confirm participant safety and data integrity.
• Address safety issues, support medical data review and assist in pharmacovigilance activities.
• Identify trial risks, develop mitigation strategies and ensure compliance with FDA, EMA, ICH and GCP guidelines.
• Organise and lead advisory boards and safety monitoring boards.
• Participate in bid‑defence meetings and proposal activities.

Required profile

• Medical Doctor degree with a Gastroenterology fellowship (mandatory).
• Minimum 10 years of practising MD experience.
• Prior research or clinical‑trial industry experience is a plus.
• Full professional proficiency in English.
• Strong communication and presentation abilities.

Required skills

• Proficiency with MS Office applications.