Clinical Operations Study Country Lead

<ul><li>Location: Prague, Czechia</li><li>Job type: Permanent, Full-time</li><li>Travel: 10% in country</li><li>Flexible working: Hybrid</li></ul><p><br/>About the job</p><p></p><p>Ready to push the limits of what’s possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.</p><p></p><p>As a Clinical Operations Study Country Lead (COSCL) you will be accountable for the strategic planning, management and performance of assigned clinical trials for your country. From country allocation until study closure at the Clinical Study Unit (CSU) level including study country timelines, study country budget and study conduct in accordance with Sanofi Standard Operating Procedures (SOPs) and/or Quality Documents (QD)s and ICH/GCP and regulatory guidelines &amp; directives.</p><p></p><p>We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?</p><p></p><p><b>Main responsibilities:</b></p><ul><li><b>Strategize and Lead Start-Up Activities: </b>Ensure and implement local strategies for effective startup strategies, identify optimal site mapping, and coordinate activities with Site Engagement Lead (SEL) and Local medical Expert (LME) . Organize and lead local kick-off meetings to ensure timely progress. Implement and oversee recruitment and retention planning.</li><li><b>Lead Local Study Execution:</b> Oversee the performance of clinical studies at the country level, ensuring compliance with global and local plans and KPIs, and local regulation requirements including HA/EC communication where needed. Drive study performance with risk assessment and mitigation strategies, support site staff and monitoring teams, and represent the CSU in Core Study Team meetings.</li><li><b>Budget Management:</b>  Maintain and optimize the country study budget and contract negotiations with sites, addressing any financial issues promptly.</li><li><b>Facilitate Effective Communication:</b> Serve as the main link to the local Sanofi, CSU and monitoring team, and to the global study team, ensuring adequate sharing of key actions/plans. Is engaged in site engagement activities and work closely with LMEs/SELs/CSU team lead to drive country strategy. Coordinates local study team meetings and collaborate with Vendor Functional Line Managers (FLM) to drive quality and study KPIs. .</li><li><b>Resource Management:</b> Proactively address and propose possible mitigation plan for vendor resource-related risks and issue to CSU Team lead.</li><li>Digital application skills and AI implementation in study management planning</li><li><b>Strategic Interface</b>: Act as the key strategic interface at the country level with internal and external stakeholders to manage operational processes and accelerate trial conduct. Key interfaces include:<ul><li>Globally: Clinical Operations Study Lead (COSL), Data Management, Vendor Management, Study Medical Manager, Clinical Supply Chain Study Manager, Patient Recruitment and Retention Lead, and other Core Study Team members.</li><li>Locally: CSU Team Lead, Clinical Research Associate (CRA), Clinical Project Assistant (CPA),Local medical Expert (LME), Site Engagement Lead (SEL), Medical Science Liaisons (MSL), and other relevant roles.</li></ul></li></ul><p></p><p>About you </p><p></p><p><b><span>Requirements/Qualifications:</span></b></p><p></p><p><b>Education:</b></p><ul><li>University degree in Nursing, Biochemistry or related Natural Science</li></ul><p></p><p><b>Experience:</b></p><ul><li>Experience in clinical research, preferably combined with project management and time spent as a field monitor or site coordinator.</li><li>Solid understanding of clinical development process and relevant therapeutic/disease area(s).</li></ul><p></p><p><b>Skills:</b></p><ul><li>Strong project management, problem-solving, and risk-management skills in a clinical study environment.</li><li>Proficiency in data analytics and the use of digital tools, platforms, and systems.</li><li>Excellent interpersonal skills with the ability to build and maintain trustful relationships with various internal and external stakeholders.</li></ul><p></p><p><b>Languages:</b></p><ul><li>Czech and English – full professional proficiency in verbal and written.</li></ul><p></p><p><b>Travel</b>:</p><ul><li>Willingness to travel up to 10% within the country.</li></ul><p></p><p>Why choose us?</p><p></p><ul><li>Bring the miracles of science to life alongside a supportive, future-focused team.</li><li>Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.</li>