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19 hours ago
This is a critical role that involves medical oversight of global clinical trials. The successful candidate will be responsible for ensuring compliance across all aspects of clinical trials and related activities.
Main Responsibilities:- Provide medical oversight of clinical trials at all stages, contributing to operational trial deliverables, meeting quality, compliance, and performance standards.
- Drive portfolio/trial medical feasibility within the Global Development framework, providing country clinical strategic guidance and proposals in collaboration with Study and Site Operations Team and Medical Affairs Team.
- Identify and propose new sites for clinical trials, analysing capability, assessing patient pool and country treatment landscape, and making recommendations for potential trial inclusion.
- Provide robust indication and protocol training to CRAs, CSMs, RSMs and other functions in the country as needed.
- Responsible for medical-related education, implementation and compliance to protocol, standards (SOPs) and best practices for clinical development within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned.
- Provide medical expertise to clinical/operational activities for patient eligibility, medical question-management, safety, amendments, etc.
- Collaborate cross-functionally for the early product launch planning process to ensure Global Development trials conducted are aligned with the local country strategy.
- Medical Degree (MD, MBBS).
- Proven experience in medical practice or pharmaceutical industry experience with a background in clinical trials/medical affairs/life sciences/research in all aspects of drug development including clinical research, GCP, and local regulatory requirements.
- Experience in Haematology and Oncology clinical trials is valuable.
- Demonstrated experience in managing projects, feasibility conduct and the execution of strategic plans from a medical perspective.
- Outstanding internal and external stakeholder engagement experience.
- Located in Sydney, with flexible working options.
This is an exciting opportunity to work in a dynamic environment, contributing to the success of our organization through your medical expertise and experience.
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