Clinical Operations Study Country Lead I (COSCL) - all genders

• Location: Frankfurt Office or Berlin Office
• Languages required: German and English Business fluent (Verhandlungssicher)
• Career level: Experienced / Senior Project Manager; individual contributor (Bitte beachten Sie, die Rolle ist kein/e Leitende/r Angestellte/r)

About the job

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In the Clinical Study Unit, you’ll drive breakthroughs that could turn the impossible into possible for millions.

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:

Strategic Study Leadership:

• Develop and execute local study country strategies and lead country start-up activities
• Create early recruitment and retention strategies in collaboration with cross-functional teams
• Identify optimal site mapping and establish site engagement strategies
• Organize local kick-off meetings and lead set-up activities to ensure timely study initiation

Operational Excellence:

• Own local-level study performance, ensuring compliance with global and local study plans
• Manage project management tools (CTMS, Control room) at country level
• Drive study performance through proactive risk assessment and mitigation strategies
• Represent your Clinical Study Unit (CSU) at Core Study Team meetings
• Provide strategic support to site staff and monitoring teams

Financial Stewardship:

• Own and optimize study budgets at country/cluster level
• Collaborate on Local Study Budget Form (LSBF) preparation ensuring cost optimization
• Maintain and monitor country study budgets throughout the study lifecycle
• Proactively escalate budget-related risks and initiate updates as needed

Stakeholder Management & Communication:

• Serve as the main interface between global and local study teams
• Collaborate with Vendor Functional Line Managers to drive quality and study KPIs
• Coordinate with Medical Advisors, Site Engagement Leads, and other key stakeholders
• Establish productive partnerships with Medical Affairs for trial conduct activities

Quality & Compliance Assurance

• Ensure data quality, patient safety, and compliance with study metrics
• Oversee appropriate data collection and query resolution processes
• Collaborate on audit and inspection activities
• Maintain system readiness (PAI, TMF, CTMS) and ensure CRA training compliance

About you

Required Qualifications and Experience:

• Bachelor's or Master's degree (or higher) in medicine, pharmacy, biology, biochemistry, or related natural science

• Mandatory: Clinical Research experience

• Preferred: Project management experience combined with field monitor or site-coordinator background

• Solid knowledge of clinical development processes and relevant therapeutic areas

Core Competencies:

• Strong project management skills with proven ability to manage complex timelines

• Excellent problem-solving and risk-management capabilities in clinical study environments

• Proficiency in data analytics and digital tools, platforms, and systems

• Change management skills with adaptability to evolving study requirements

• Outstanding interpersonal skills with ability to build trustful relationships across diverse stakeholder groups

Additional Requirements:

• Fluent in English and German

• Willingness to travel up to 10% (in-country travel)

• Strong understanding of ICH/GCP and regulatory 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.
• Benefit from a well-thought-out benefits package that rewards your contribution and commitment.
• We take care of you and your family with a wide range of health and social such as high-quality healthcare, numerous prevention programs and coverage for long-term illness. Our 14-week paid family leave for both parents is outstanding as well as a wide range of childcare benefits.
• Start your career at an attractive location in the center / in the capital of Germany and experience our modern working environment and benefit from hybrid, flexible working time models.

PursueProgress. 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.  Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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