Morristown, NJ, 07960, USA
11 hours ago
Clinical Operations Study Country Lead (COSCL)
**Job Title:** Clinical Operations Study Country Lead (COSCL) **Location:** US Remote **About the Job:** Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. We are seeking a highly motivated and experienced Clinical Operations Study Country Lead to support US clinical trial operations. The COSCL will be a strategic leader within the Clinical Study Unit (CSU), accountable for the planning, execution, and oversight of clinical trials from country allocation through study closure and archiving. This role ensures compliance with Sanofi SOPs, ICH/GCP, and local regulatory requirements, while leveraging AI-driven solutions to optimize processes. As the primary interface between the CSU and the global study team (COSL), the COSCL represents the country in global meetings, escalates risks, and owns national-level decisions to ensure successful study delivery. The role involves close collaboration with internal and external stakeholders to enhance operational efficiency and accelerate trial execution. The ideal candidate will possess a deep understanding of current digital technologies, AI applications, and direct experience implementing innovative solutions to deliver transformative approaches for our patients. Job Purpose: Clinical Operations Study Country Lead: + This person will lead the strategic and operational execution of clinical trials at the country level + Ensure alignment with global study objectives, Sanofi SOPs and local regulatory requirements while driving innovation through AI and digital transformation + Accountable for study delivery, end to end planning, compliance and performance + Key role in advancing Sanofi’s digital clinical development strategy + Contribute to Sanofi’s commitment to accelerate the development of new drugs for all patients through our clinical trials We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? **Main Responsibilities:** **Clinical Operations Study Country Lead:** + 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 **About You:** **Basic Qualifications** + US: Bachelor's Degree within health, science, or engineering role with 3 years experience. **Preferred Qualifications:** + Knowledge of clinical trial life cycle + Experience in CRO environment + Understanding of startup activities + Exposure to FDA requirements and guidelines **Why Choose Us?** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. \#GD-SA \#LI-SA \#LI-Remote \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. _North America Applicants Only_ The salary range for this position is: $100,500.00 - $145,166.66 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) . Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
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