摘要
As the CRMA your responsibility lies within the development of Global Clinical Trials – this includes medical oversight for all trials, portfolio and/or protocol medical feasibility, scientific engagement of investigators, protocol and TA training for internal and external stakeholders, medical issue or question management, safety review, strategic input in pre-launch planning.
You will drive compliance across all aspects of clinical trials and CRMA related activities. It will be critical to ensure good communication and stakeholder management cross-functionally within the local country organisation as well as between global and regional teams.
About the Role
- Medical oversight of clinical trials across all stages and contribute to operational trial deliverables, according to timelines, quality/compliance, and performance standards.
- Drive portfolio/trial medical feasibility within the Global Development framework and provide 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, analyse capability, assess patient pool and country treatment landscape, and make 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.
- Support medical/clinical team discussions with local regulatory interactions as needed.
What you’ll bring to the role:
- Post-Graduate Science qualification is essential. Medical Degree (MD, MBBS) preferred.
- 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 essential.
- Demonstrated experience in managing projects, feasibility conduct and the execution of strategic plans from a medical perspective.
- Outstanding internal and external stakeholder engagement experience.
- Location is based in Sydney, with flexible working options.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture
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