摘要
Location: Sydney, Australia #LI-Hybrid
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
About the Role:
As the Clinical Research Medical Advisor (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 organization as well as between global and regional teams.
About the Role
Key Responsibilities:
- 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.
Essential Requirements:
- 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.
- Location is based in Sydney, with flexible working options.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: http://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. http://www.novartis.com/careers/benefits-rewards
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: http://talentnetwork.novartis.com/network
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: http://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
