Medical Monitor – Gastroenterology
PSI CRO · Milan
Job description
About the role
As a Medical Monitor specializing in Gastroenterology, you will join PSI’s international Medical Monitoring team to ensure patient safety and data integrity across global clinical studies. You will act as the primary medical liaison for internal project teams, study sites, and sponsors, applying your clinical expertise to support the development of new therapies.
Key responsibilities
- Serve as the medical point of contact for internal teams, study sites, and sponsors on protocol and GCP‑related matters.
- Advise clients, regulatory agencies, and third‑party vendors on medical issues throughout the trial lifecycle.
- Collaborate on the preparation of clinical development plans, protocols, investigator brochures, and scientific presentations.
- Review and analyze clinical data to ensure participant safety and compliance with approved protocols.
- Address safety concerns, support medical data review, and participate in pharmacovigilance activities.
- Identify trial risks, develop mitigation strategies, and lead safety monitoring boards.
- Participate in bid defense meetings, proposal activities, and advisory board organization.
Required profile
- Medical Doctor (MD) degree.
- Board‑certified Gastroenterology fellowship.
- Prior experience as a practicing MD; clinical research or trial experience is a plus.
- Full professional proficiency in English.
- Strong communication, presentation, and analytical abilities.
- Team‑oriented, detail‑focused problem‑solver.
Required skills
- Proficiency with MS Office applications.
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Published 1 mese fa
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PSI CRO
Milan
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