Clinical Operation Study Country Lead
Clinical Operation Study Country Lead
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About the Job
The Clinical Operation Study Country Lead (COSCL) is responsible for the setup and progress of clinical trials, observational studies, or special programs within their country in the Italy Cluster. They ensure compliance with Sanofi Group quality standards and regulations, as well as meeting forecasted timelines, milestones, and budgets.
About Sanofi Business Unit
As people live longer, chronic conditions are increasing. New viruses and diseases emerge, while old enemies like cancer and neurodegenerative diseases persist. Sanofi is driven by these health challenges.
We are passionate about scientific excellence, knowing that our work today can improve lives tomorrow. We aim to transform scientific knowledge into innovative therapies for patients, focusing on unmet medical needs and being a trusted partner in health journeys.
Our R&D community includes scientists, physicians, technicians, engineers, and others committed to scientific leadership. Our goal is breakthrough innovation to transform, extend, and save lives.
Main Responsibilities
- Strategic planning, management, and performance of assigned clinical trials from country allocation through study closure, including timelines, budgets, and conduct in accordance with Sanofi SOPs, QDs, ICH/GCP, and regulatory guidelines.
- Serving as the key strategic interface at the country level with internal and external stakeholders to manage operational processes and accelerate trial conduct both globally and locally. Represent the unit at Core Study Team meetings.
- Identify, evaluate, and implement AI-driven solutions to streamline processes and enhance efficiency. Good knowledge of AI tools used in daily activities is required.
- Promote innovation by scouting and piloting new technologies and methodologies. Support teams in adopting digital solutions and agile practices, leveraging AI-powered solutions to optimize workflows and drive outcomes.
About You
- Experience: Clinical research experience is mandatory, preferably combined with project management and field monitoring or site coordination. Solid knowledge of clinical development processes and relevant therapeutic areas. Experience with agile methodologies and design thinking.
- Skills: Strong project management skills, familiarity with AI tools (e.g., generative AI, automation platforms, machine learning frameworks), digital literacy, problem-solving, risk management, data analysis, change management, interpersonal skills, knowledge of current trends in digital clinical trials and quality management, and FDA/EMA inspection readiness.
- Education: Bachelor’s degree in biology, nursing, biochemistry, pharmacy, chemical and pharmaceutical technology, or related natural sciences.
- Languages: Fluent in English and the country language.
Why Choose Us?
- Work alongside a supportive, future-focused team to bring scientific miracles to life.
- Opportunities for growth and career advancement, both locally and internationally.
- Competitive rewards package recognizing your contributions.
- Comprehensive health and wellbeing benefits, including healthcare, wellness programs, and parental leave.
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Sanofi
Why Sanofi
We are transforming medicine, reinventing work practices, and enabling our people to excel in their careers and personal lives. Our inclusive, trust-based environment supports growth and work-life balance.
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