Medical Monitor – Gastroenterology (Singapore)
PSI CRO · Singapour
Job description
About the role
Join PSI’s Medical Monitoring team in Singapore as a Medical Monitor specializing in gastroenterology. You will work with an international group of medical professionals 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, support pharmacovigilance activities and participate in bid‑defense meetings.
- Identify program risks, develop mitigation strategies with Clinical Operations, and organise advisory 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 major 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 clinical monitors and physician investigators and build constructive relationships at all levels.
Required skills
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Published 1 month ago
Expires 3 weeks from now
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PSI CRO
Singapour
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