Job title: Clinical Operations Study Country Lead

Location: Warsaw, Poland Hybrid: 60% office based, 40% remotePermanent, 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 colleaguesConduct strategic site mapping and establish engagement plans within the teamDrive setup activities to maintain progress according to study timelines with proactive planning

Local Study Management

Take full ownership of local study performance and timeline complianceEstablish, maintain and adapt digital project management tools at country levelImplement risk assessment and mitigation strategies to drive performanceManage site engagement plansRepresent 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 lifecycleEnsure timely escalation of budget-related issues/risks

Communication & Coordination

Serve as primary liaison to local monitoring teams for study managementCollaborate with Vendor managersPlan/participate in site engagement activitiesCoordinate local team meetings and establish collaboration with Medical Affairs

Quality & Compliance

Ensure data quality, patient safety and compliance with study metricsOversee proper data collection and query resolution processesCollaborate with Quality Lead on audit and inspection activitiesMaintain 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 processStrong skills in Project Management

Soft and technical skills:

Problem-solving and risk-management skills in a clinical study environmentData analytic skills and use of digital tools, platforms and systemsChange management skillsInterpersonal 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 othersAt 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!