Job Description
Medical Monitor (Gastroenterology) | Remote – Sydney, Melbourne
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Date published: Sep 2, ****, 10:40 AM
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Location
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Remote role, with Sydney or Melbourne preferred as your home location
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Description
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This is a senior medical role within a CRO's medical monitoring team.
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protecting participant safety, assuring data integrity, and advising sponsors, sites and study teams on medical matters from protocol design through to final reporting
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advising clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters
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contributing to clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts and scientific presentations
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reviewing and analysing clinical data to safeguard the safety of study participants
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ensuring reported data is accurate, complete and verifiable, and that trial conduct complies with the approved protocol and amendments
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addressing safety issues raised across the study by sites and the study team, and support pharmacovigilance activities
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identifying program risks and implement mitigation strategies with Clinical Operations
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organising and leading clinical development advisory boards and safety monitoring boards
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participating in bid defence meetings
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ensuring study-team compliance with local regulatory agencies,



ICH and GCP guidelines
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reviewing and signing off clinical documents for medical relevance
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We're looking for someone with the following qualifications, experience and capabilities:
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Medical Doctor (MD) degree
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Board certification in Gastroenterology preferred
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Prior experience in clinical research
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Clinical experience in a major therapeutic area (oncology, infectious disease, gastroenterology, haematology or internal medicine) is desirable
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Familiarity with clinical research practice and local regulations; experience of local health-authority interactions leading to drug approval is strongly preferred
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Able to train clinical monitors and physician investigators, and build constructive, trusted relationships at all levels
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Solid leadership, communication, presentation and organisational skills
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Sound critical thinking and problem-solving, able to carry the role with minimal guidance
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We acknowledge and pay respect to the Traditional Custodians and Elders — past, present and emerging — of the lands and waters on which RACP members and staff live, learn and work. RACP acknowledges Māori as tangata whenua and Te Tiriti o Waitangi partners in Aotearoa New Zealand.
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Find out more about our commitment to Aboriginal and Torres Strait Islander and Māori health equity.

📌 Medical Monitor (Gastroenterology) | Remote - Sydney, Melbourne (Victoria)
🏢 Royal Australasian College of Physicians
📍 Victoria