Clinical Operations Study Country Lead
Sanofi
8 hours ago
Remote friendly (United States)
United States
Operations
Clinical Operations Study Country Lead (COSCL) — US Clinical Trial Operations
Main Responsibilities:
- Lead strategic planning, execution, and oversight of US clinical trials, aligned 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; 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, site 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 for AI use
- Manage local study budgets; monitor financial performance; ensure data integrity, patient safety, audit readiness, and quality oversight
- Use 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
- Minimum 3 years of clinical research experience, 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
- Proficiency in project, risk, and change management methodologies
- Fluent in English; willingness to travel
Preferred Qualifications:
- Expertise 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 study teams day-to-day; make decisions and delegate effectively
- Skills in strategic vision and long-term team development
- Ability to identify, assess, and monitor study-related risks
- Proficient in planning/scheduling/tracking study timelines and deliverables
- Strong relationship-building with investigators, vendors, and internal teams
- Foundational scientific understanding of clinical studies, trial processes, regulatory requirements, and study design
- Ability to identify issues and develop practical solutions; oversee vendor performance
Benefits (as stated):
- Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave
Main Responsibilities:
- Lead strategic planning, execution, and oversight of US clinical trials, aligned 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; 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, site 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 for AI use
- Manage local study budgets; monitor financial performance; ensure data integrity, patient safety, audit readiness, and quality oversight
- Use 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
- Minimum 3 years of clinical research experience, 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
- Proficiency in project, risk, and change management methodologies
- Fluent in English; willingness to travel
Preferred Qualifications:
- Expertise 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 study teams day-to-day; make decisions and delegate effectively
- Skills in strategic vision and long-term team development
- Ability to identify, assess, and monitor study-related risks
- Proficient in planning/scheduling/tracking study timelines and deliverables
- Strong relationship-building with investigators, vendors, and internal teams
- Foundational scientific understanding of clinical studies, trial processes, regulatory requirements, and study design
- Ability to identify issues and develop practical solutions; oversee vendor performance
Benefits (as stated):
- Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave