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 Sanofiu2019s mission u2014 where deep immunoscience meets bold, AI-powered research. In the Clinical Study Unit, youu2019ll drive breakthroughs that could turn the impossible into possible for millions. About Sanofi: Weu2019re an R&D-driven, AI-powered biopharma company committed to improving peopleu2019s lives and delivering compelling growth. Our deep understanding of the immune system u2013 and innovative pipeline u2013 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 peopleu2019s 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 itu2019s 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. 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 whatu2019s never-been-done-before. Youu2019ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve peopleu2019s lives? Letu2019s Pursue _Progress_ and Discover _Extraordinary_ u2013 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 (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) ! \Li-onsite \Li-hybrid Pursue _progress_, discover _extraordinary_ Better is out there. Better medications, better outcomes, better science. But progress doesnu2019t happen without people u2013 people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, letu2019s 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) ! 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)