Clinical Operations Study Country Lead I / all genders

About the job

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 elevate 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!

About you

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!

• Education : University degree in medicine, pharmacy, biology, biochemistry or related natural science
• Experience : Clinical research experience is mandatory, preferably combined with project management experience and time as field monitor or site coordinator
• Technical skills : Solid knowledge of clinical development process and relevant therapeutic/disease areas; GCP certificate; strong data analytic skills and proficiency with digital tools, platforms and systems
• Soft skills : Strong project management abilities; problem-solving and risk-management skills in clinical study environments; change management capabilities; interpersonal skills with ability to create and foster trustful relationships with internal and external stakeholders
• Languages : Fluent in German and English
• Travel : Willingness to travel approximately 10-20% within country

Why choose us?

• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.
• Enjoy opportunities to collaborate beyond your area of expertise, working with diverse teams across science, clinical, and digital fields to spark new ideas and drive breakthroughs.
• Accelerate your professional development with structured career paths designed for both scientific and leadership advancement. Grow in ways you never imagined through bold moves that stretch your potential, cross moves into other business areas, and short-term gigs that build your scientific expertise.
• Join a workplace where diversity, equity, and inclusion are at the core, with Employee Resource Groups and leadership programs that celebrate every voice.
• Achieve genuine work-life balance in a supportive R&D environment.
• Enjoy outstanding benefits, including flexible working options, comprehensive healthcare, and well-being programs designed to help you thrive.

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