Sanofi
As Clinical Operations Study Country Lead I (COSCL) within our Clinical Operations team, you'll be the country-level operational lead for clinical studies in GSA (Germany, Switzerland, Austria), owning strategic planning, management, and performance from country allocation to study closure. Ready to get started?
You'll be the strategic hub at country level – connecting internal and external stakeholders to accelerate trial execution. You'll collaborate globally with COSL, Data Management, Vendor Management, Study Medical Managers, and other Core Study Team members, while locally partnering with Clinical Research Associates, Clinical Project Assistants, Medical Advisors, Site Engagement Leads, and Medical Science Liaisons.
About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main responsibilities:
Set Up Local Study Strategy: Develop and initiate recruitment and retention strategies, identify successful site mapping, and set up site engagement plans. Organize local kick-off meetings and lead set-up activities to ensure progress.
Manage Study Execution: Own local study performance, ensure compliance with timelines, drive performance with risk assessment, manage site engagement, and support site staff. Represent CSU in Core Study Team meetings and escalate issues as needed.
Optimize Study Budget: Collaborate on budget preparation, manage financial resources, and address budget-related issues promptly.
Facilitate Communication: Act as the main link to the local monitoring team, collaborate with Vendor Functional Line Managers, plan and participate in engagement activities, coordinate local team meetings, and establish collaboration with Medical Affairs.
Ensure Quality and Compliance: Maintain data quality, patient safety, and compliance with study metrics. Ensure CRA training, collaborate on audit activities, and ensure system readiness.
AI expertise and data-driven thinking are essential – this role goes beyond traditional project management!
Bring your passion for AI and data-driven thinking to clinical research that makes a real difference. If you're excited about using data to drive smarter decisions and improve patient lives, we want to meet you!
#LI-Hybrid
#ClinicalDevelopment
#ClinicalTrials
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 and check out our Diversity Equity and Inclusion actions at sanofi.com!
The salary range for this position is :€79 104,00 - €118 656,00
Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.