Clinical Operations Study Country Lead I / all genders

Clinical Operations Study Country Lead I / all genders
Frankfurt am Main, Germany Salary Range EUR 79,104.00 - 118,656.00

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.

Your main responsibilities will be:

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.

t management and drive smarter clinical trial decisions 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.

#LI-Hybrid

Pursue Progress . Discover Extraordinary .

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what's never-been-done-before. You'll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people's lives? Let's Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

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.

Please note that for Tariff positions in Germany, compensation is based on the federal collective bargaining agreement of the chemical industry.