Clinical Operations Country Study Lead (18 month FTC)

• Location: Diegem, Belgium
• Job type: 18 month FTC, Full time

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.

About the job

As a Clinical Operations Study Country Lead (COSCL) within our Clinical Operations team, you'll lead the strategic planning, management, and performance of clinical trials at the country level. Ready to drive innovation in clinical research?

As the country-level operational lead, you'll be the key strategic interface between internal and external stakeholders, managing operational processes to accelerate trial conduct from country allocation until study closure. You'll represent your Clinical Study Unit (CSU) at Core Study Team meetings and work closely with global teams including the Clinical Operations Study Lead (COSL), Data Management, Vendor Management, and other core study team members. Locally, you'll collaborate with Clinical Research Associates (CRAs), Clinical Project Assistants (CPAs), Medical Advisors (MDAs), Site Engagement Leads (SELs), and other relevant roles to ensure seamless execution of clinical trials.

Main responsibilities:

• Leading country-level operational strategy for clinical trials, from allocation to study closure, including developing comprehensive plans for site selection, patient recruitment, and study execution
• Developing and implementing local recruitment and retention strategies in collaboration with key stakeholders, such as Site Engagement Leads and Medical Advisors, to ensure optimal patient enrollment and study success
• Managing study performance, timelines, and budget at the country level, ensuring compliance with SOPs, ICH/GCP, and regulatory guidelines while optimizing resource allocation and study efficiency
• Driving effective communication between all local parties involved in the study, aligning common goals and defining best strategies through regular team meetings, status updates, and cross-functional collaboration
• Collaborating with global teams to accelerate trial conduct and optimize operational processes, representing the country's perspective in Core Study Team meetings and contributing to global strategic decisions
• Maintaining quality and compliance, ensuring data quality, patient safety, and adherence to study metrics by overseeing monitoring activities, conducting regular quality checks, and implementing corrective actions as needed
• Implementing risk assessment and mitigation strategies, proactively escalating and addressing issues by conducting regular risk reviews, developing contingency plans, and coordinating with global teams on risk mitigation efforts
• Owning and managing the country-level study budget, including preparing Local Study Cost Requests (LSCRs), tracking expenses, and initiating updates as needed to ensure financial accountability and optimization

About you

• Minimum 5-6 years of experience in clinical research
• Background as a Field monitor or Site-Coordinator
• Solid knowledge of clinical development processes and relevant therapeutic/disease areas
• Project management and problem-solving skills in a clinical study environment
• Data analysis skills and proficiency with digital tools, platforms, and systems
• Excellent interpersonal and communication skills, with the ability to build relationships with a diverse group of stakeholders
• Bachelor's degree in a relevant field
• Fluency in English, Dutch and French
• Willingness to travel up to 5%

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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