Lead Clinical Operations & Governance at CARED, a health - tech revolutionising allied health. Shape the future of care in Australia and beyond.
About the role
- Clinical Operations Study Country Lead overseeing US clinical trials at Sanofi. Leading strategic planning, execution, and ensuring compliance with regulations and digital transformation initiatives.
Responsibilities
- Lead strategic planning, execution and oversight of US clinical trials, ensuring alignment with global strategy, timelines, budgets and local regulatory guidelines
- Lead digital transformation by identifying, and implementing AI-driven solutions to enhance trial efficiency, site performance and patient engagement, and promote ethical AI use, data privacy and governance
- Represent the US in global study meetings, escalate risks, make global-level decisions to support study success
- Oversee study start-up activities, including feasibility, selection and recruitment strategies by leveraging digital tools and AI analytics to ensure site readiness and performance
- Foster strong communication with internal teams, vendors and external partners, and lead stakeholder communication, sharing best practices for AI use and learnings
- Manage local study budgets, monitor financial performance and ensure data integrity, patient safety, audit readiness and quality oversight
- Leverage data analytics to inform decisions, identify digital opportunities and develop business cases that drive operational value
Requirements
- Bachelor's Degree within health, science, or engineering field
- Minimum 3 years of experience in clinical research, including project management and clinical trial oversight
- Strong knowledge of GCP, ICH guidelines and US regulatory requirements
- Familiarity with machine learning in healthcare, and understanding of AI ethics and governance
- Excellent written and verbal communication skills with strong stakeholder management
- Proficient in project, risk and change management methodologies
- Fluent in English
- Willingness to Travel
Benefits
- Health insurance
- Prevention and wellness programs
- Gender-neutral parental leave for at least 14 weeks
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