Job title: Clinical Operations Study Country Lead
- Location: Warsaw, Poland
- Hybrid: 60% office based, 40% remote
- Permanent, Full-time
About the job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Clinical Study Unit as Clinical Operations Study Country Lead and you’ll serve as the operational cornerstone for clinical studies, taking full ownership and accountability for trials from country allocation through study closure within your assigned Clinical Study Unit. You will drive strategic planning, comprehensive management, and performance optimization of clinical trials while ensuring strict adherence to timelines, budget parameters, and all regulatory requirements. Your role demands masterful coordination with both global stakeholders (including Core Study Team members and Vendor Management) and local partners (such as Clinical Research Associates and Medical Advisors) to accelerate trial conduct effectively. You will represent your CSU at Core Study Team meetings, ensuring local perspectives are integrated into global strategies while maintaining compliance with Sanofi SOPs, Quality Documents, and ICH/GCP guidelines. Working under the CSU Team Lead while collaborating functionally with the Clinical Operations Study Lead, you will be fully accountable for delivering studies as planned, combining strategic thinking with operational excellence to drive successful clinical trial outcomes.
Main responsibilities:
Country Strategy & Setup
- Develop and lead local recruitment/retention strategies with cross-functional colleagues
- Conduct strategic site mapping and establish engagement plans within the team
- Drive setup activities to maintain progress according to study timelines with proactive planning
Local Study Management
- Take full ownership of local study performance and timeline compliance
- Establish, maintain and adapt digital project management tools at country level
- Implement risk assessment and mitigation strategies to drive performance
- Manage site engagement plans
- Represent CSU in Core Study Team meetings and escalate performance issues with proposed solutions
Budget Management
- Actively prepare and manage country study budget throughout the study lifecycle
- Ensure timely escalation of budget-related issues/risks
Communication & Coordination
- Serve as primary liaison to local monitoring teams for study management
- Collaborate with Vendor managers
- Plan/participate in site engagement activities
- Coordinate local team meetings and establish collaboration with Medical Affairs
Quality & Compliance
- Ensure data quality, patient safety and compliance with study metrics
- Oversee proper data collection and query resolution processes
- Collaborate with Quality Lead on audit and inspection activities
- Maintain PAI readiness
About you
Experience:
- Experience in clinical research is mandatory, preferably in combination with experience in project management and certain time as field monitor.
- Solid knowledge of clinical development process
- Strong skills in Project Management
Soft and technical skills:
- Problem-solving and risk-management skills in a clinical study environment
- Data analytic skills and use of digital tools, platforms and systems
- Change management skills
- Interpersonal skills with ability to create and foster trustful relationships with several internal and external stakeholders
Education: Medical degree or Master’s degree in life science ( pharmacy, biotechnology, nursing etc)
Languages: Fluent in English and Polish (written and spoken)
Travel; 10% travel (in-country travel)
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 through promotions, lateral moves, or international assignments, your professional journey is in your hands.
- Enjoy a thoughtfully crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family with our wide range of health and wellbeing benefits: high-quality healthcare coverage; Wellness programs; 14 weeks of gender-neutral parental leave; Employee Assistance Program offering free, confidential counseling and others
- At Sanofi, we're not just offering a job – we're inviting you to be part of a mission to improve lives through the power of science. Join us in making a difference!
- Company car available
Pursue Progress. Discover Extraordinary.
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s 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, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s 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 and check out our Diversity Equity and Inclusion actions at sanofi.com!
