Medical Monitor (Gastroenterology)

About the role

PSI is seeking an experienced Gastroenterology Medical Monitor to join its international Medical Monitoring team. The role involves providing medical expertise for global clinical studies, ensuring patient safety, and supporting the development of new therapies.

Key responsibilities

• Act as the medical point of contact for internal project teams, study sites, and sponsors.
• Advise on medical matters to clients, regulatory agencies, and third‑party vendors.
• Collaborate on clinical development plans, protocols, investigator brochures, and scientific presentations.
• Review and analyse clinical data to verify safety and compliance with protocol and GCP guidelines.
• Address safety issues, support medical data review, and participate in pharmacovigilance activities.
• Identify trial risks and implement mitigation strategies with relevant departments.
• Organise and lead advisory boards and safety monitoring boards.
• Contribute to bid defense meetings, proposal activities, and ensure compliance with FDA, EMEA, ICH, and GCP regulations.

Required profile

• Medical Doctor degree with a Gastroenterology Fellowship certification.
• Minimum 10 years of practice as an MD; clinical trial or research experience is a plus.
• Full professional proficiency in English.
• Strong communication, presentation, and analytical abilities.
• Detail‑oriented, problem‑solver, and able to work effectively in multidisciplinary teams.

Required skills

• Proficiency with MS Office applications.