Clinical Operations Study Country Lead
Sanofi
4 hours ago
Remote friendly (Morristown, NJ)
United States
Clinical Research and Development
Clinical Operations Study Country Lead (COSCL)
Main 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 and make global-level decisions to support study success
- Oversee study start-up activities (feasibility, selection and recruitment strategies) using digital tools and AI analytics to ensure site readiness and performance
- Foster communication with internal teams, vendors and external partners; lead stakeholder communication and share best practices/learnings for AI use
- Manage local study budgets; monitor financial performance; 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
Basic Qualifications
- Bachelor’s degree in health, science, or engineering
- 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; understanding of AI ethics and governance
- Excellent written/verbal communication and stakeholder management
- Proficient in project, risk and change management methodologies
- Fluent in English
- Willingness to travel
Preferred Qualifications
- Experience assessing and implementing digital technologies in clinical development
- Hands-on experience with AI-powered tools and data analytics
- Certifications: CPMAI, AIPM, or Google AI
- Proficient with digital tools/platforms for study management, communication, data collection, and reporting
- Ability to guide/motivate teams and delegate effectively
- Strategic vision and long-term team development
- Risk identification, assessment and monitoring
- Planning/scheduling/tracking study timelines and deliverables
- Relationship building with investigators, vendors and internal teams
- Foundational understanding of scientific principles, trial processes, regulatory requirements and study design
- Issue identification and practical problem-solving
- Experience selecting, evaluating and overseeing vendor performance
Benefits (explicitly stated)
- Health and wellbeing benefits including high-quality healthcare and prevention/wellness programs
- At least 14 weeks’ gender-neutral parental leave
Main 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 and make global-level decisions to support study success
- Oversee study start-up activities (feasibility, selection and recruitment strategies) using digital tools and AI analytics to ensure site readiness and performance
- Foster communication with internal teams, vendors and external partners; lead stakeholder communication and share best practices/learnings for AI use
- Manage local study budgets; monitor financial performance; 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
Basic Qualifications
- Bachelor’s degree in health, science, or engineering
- 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; understanding of AI ethics and governance
- Excellent written/verbal communication and stakeholder management
- Proficient in project, risk and change management methodologies
- Fluent in English
- Willingness to travel
Preferred Qualifications
- Experience assessing and implementing digital technologies in clinical development
- Hands-on experience with AI-powered tools and data analytics
- Certifications: CPMAI, AIPM, or Google AI
- Proficient with digital tools/platforms for study management, communication, data collection, and reporting
- Ability to guide/motivate teams and delegate effectively
- Strategic vision and long-term team development
- Risk identification, assessment and monitoring
- Planning/scheduling/tracking study timelines and deliverables
- Relationship building with investigators, vendors and internal teams
- Foundational understanding of scientific principles, trial processes, regulatory requirements and study design
- Issue identification and practical problem-solving
- Experience selecting, evaluating and overseeing vendor performance
Benefits (explicitly stated)
- Health and wellbeing benefits including high-quality healthcare and prevention/wellness programs
- At least 14 weeks’ gender-neutral parental leave