Medical Monitor

About the role

As a Medical Monitor at PSI, you will be part of an international medical monitoring team that safeguards participant safety and ensures data quality across global clinical trials. You will apply your medical expertise to support the development of new medicines and collaborate with cross‑functional teams throughout the study lifecycle.

Key responsibilities

• Provide medical advice to clients, project teams, sites, DSMBs, regulatory agencies and third‑party vendors.
• Review and analyse clinical data to confirm participant safety and compliance with the protocol.
• Prepare and review clinical development documents such as protocols, investigator brochures, annual reports, clinical study reports and scientific manuscripts.
• Identify and address safety issues, support pharmacovigilance activities and implement risk‑mitigation strategies.
• Organise and lead clinical development advisory boards and safety monitoring boards.
• Ensure study conduct complies with local regulatory requirements, ICH and GCP guidelines.
• Participate in bid defence meetings and support regulatory submissions.

Required profile

• Medical Doctor degree (MD) with board certification in a therapeutic area (e.g., Oncology, Infectious Disease, Gastroenterology, Hematology, Internal Medicine) – desirable.
• Proven experience in clinical research and familiarity with local health‑authority interactions.
• Strong ability to train and collaborate with clinical monitors and physician investigators.
• Excellent leadership, communication and presentation skills.

Required skills