Medical Monitor – Gastroenterology

About the role

Join PSI’s Medical Monitoring team in Singapore as a Medical Monitor specializing in Gastroenterology. You will work alongside an international group of medical professionals, applying your clinical expertise to ensure the safety and integrity of clinical trials and help bring new therapies to patients.

Key responsibilities

• Advise clients, project teams, sites, DSMBs, regulatory agencies and vendors on medical matters.
• Collaborate with internal departments to prepare clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts and scientific presentations.
• Review and analyse clinical data to ensure participant safety and compliance with approved protocols.
• Address safety issues, participate in bid defense meetings and support pharmacovigilance activities.
• Identify program risks, develop mitigation strategies and ensure study team compliance with local regulatory agencies, ICH and GCP guidelines.
• Organise and lead clinical development advisory boards and safety monitoring boards.

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, building constructive relationships at all levels.

Required skills