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




reviewing and signing off clinical documents for medical relevance
We're looking for someone with the following qualifications, experience and capabilities:
Medical Doctor (MD) degree
Board certification in Gastroenterology preferred
Prior experience in clinical research
Clinical experience in a major therapeutic area (oncology, infectious disease, gastroenterology, haematology or internal medicine) is desirable
Familiarity with clinical research practice and local regulations; experience of local health-authority interactions leading to drug approval is strongly preferred
Able to train clinical monitors and physician investigators, and build constructive, trusted relationships at all levels
Solid leadership, communication, presentation and organisational skills
Sound critical thinking and problem-solving, able to carry the role with minimal guidance
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.
Find out more about our commitment to Aboriginal and Torres Strait Islander and Māori health equity.
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📌 Medical Monitor (Gastroenterology) | Remote – Sydney, Melbourne
🏢 Royal Australasian College of Physicians
📍 Sydney