Job title: Clinical Operation Study Country Lead

• Location: Milan, Italy

About the Job

The Clinical Operation Study Country Lead (COSCL) is responsible for the set up and Progress of a clinical trial/observational study/special program in his/her own country in the Italy Cluster, ensuring compliance with Sanofi Group quality standards and regulations in force, the forecasted timelines, milestones and budget.

About Sanofi Business Unit

As people live longer, chronic conditions are on the rise. New viruses and diseases are emerging while old enemies like cancer and neurodegenerative diseases remain. Sanofi is driven by the scope of these health challenges.

As researchers, we’re passionate about scientific excellence because we know that what we do today may improve the lives of people tomorrow. We work to transform scientific knowledge and medical advances into cutting-edge therapies for patients. Discovering solutions to the world’s most pressing unmet medical needs is our top priority and inspires us to be the best possible health journey partner for patients.

Sanofi’s R&D community is made up of scientists, physicians, technicians, product and manufacturing engineers and many others who contribute to our scientific leadership. Our goal is breakthrough innovation that can transform, extend and potentially save lives.

Main responsibilities

• strategic planning, management and performance of assigned clinical trials from country allocation until study closure, 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 & directives.
• key strategic interface, at country level, with internal and external stakeholders to manage operational processes to accelerate trial conduct both Globally and Locally, being part and representing their unit at Core Study Team meetings.
• identify, evaluate, and implement AI-driven solutions to streamline business processes and enhance operational efficiency. For this reason, good knowledge of AI tools to be used in day by day activities is a required skill.
• promote a culture of innovation by scouting and piloting new technologies and methodologies and act as a change agent, supporting teams in adopting digital solutions and agile practices with the ability to leverage AI-powered solutions to optimize workflow efficiency and drive business outcomes.

About You

• Experience: Experience in clinical research is mandatory, preferably in combination with experience in project management and certain time as field monitor or site-coordinator. Solid knowledge of clinical development process and relevant therapeutic/disease area(s), experience with agile methodologies and design thinking.
• Soft and technical skills: Strong skills in Project Management, Familiarity with AI tools (e.g., generative AI, automation platforms, machine learning frameworks), Digital Savvy: comfortable navigating digital ecosystems and promoting digital literacy within teams; 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; knowledge of the current trends in clinical trials risk-based approach and digital technology; deep knowledge of quality issues management and FDA/EMA requirements for inspection readiness.
• Education: Bachelor’s degree in biology, nursing, biochemistry, pharmacy, chemical and pharmaceutical technology or related natural science.
• Languages: Fluent in English and country language.

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 it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare prevention and wellness programs and weeks’ gender-neutral parental leave.

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