Medical Monitor (Gastroenterology)

About the role

PSI is seeking a Medical Monitor specialized in Gastroenterology to join its international Medical Monitoring team in Taipei. The role involves providing medical expertise throughout clinical studies, ensuring patient safety, and supporting the development of new therapies.

Key responsibilities

• Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third‑party 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 raised by sites and the study team, and participate in bid defense meetings.
• Assist in pharmacovigilance activities and identify program risks, implementing mitigation strategies with Clinical Operations.
• Organise and lead clinical development advisory boards and safety monitoring boards.
• Ensure study team compliance with local regulatory agencies, ICH and GCP guidelines, and sign‑off on clinical documents for medical relevance.

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 for drug approval.
• Ability to interact with and train clinical monitors and physician investigators, building constructive relationships at all organizational levels.

Required skills

• Pharmacovigilance
• Clinical data analysis
• Regulatory compliance (ICH, GCP)