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Clinical Trials Expert
3 weeks ago
Job Title: Clinical Research Medical Advisor
">About the Role:
- As a Clinical Research Medical Advisor, you will be responsible for providing medical oversight for all clinical trials within the Global Development framework.
- You will drive compliance across all aspects of clinical trials and related activities, ensuring good communication and stakeholder management cross-functionally within the local country organisation as well as between global and regional teams.
- Key responsibilities include:
- 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.
- 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.
Working Environment:
The location is based in Sydney, New South Wales, Australia, with flexible working options available.
Commitment to Diversity and Inclusion:
Our company is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
