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Sanofi, a leading global healthcare organization, is dedicated to improving lives through the miracles of science. With a commitment to innovation, diversity, and employee development, Sanofi offers an environment where talents thrive and careers flourish. At the core of Sanofi’s success is its collaborative culture, which emphasizes continuous learning, equal opportunities, and meaningful contributions.
By joining Sanofi, you become part of a team that transforms healthcare while working to change millions of lives globally. Sanofi’s Hubs drive innovation, enhance performance, and support every department in achieving its mission.
Responsibilities in the Job
As a Study Data Manager within the Clinical Data Management (CDM) group, your primary focus will be on delivering accurate and reliable clinical study data while coordinating cross-functional teams. Key responsibilities include:
- Data Quality Oversight: Ensuring high-quality deliverables such as Case Report Forms (CRFs), Data Management Plans, and Data Validation Specifications.
- Team Collaboration: Liaising with internal teams like Global Study Managers, Statisticians, and Pharmacovigilance experts to align study timelines and updates.
- Risk-Based Data Cleaning: Implementing effective data validation strategies with an emphasis on risk-based approaches.
- Protocol Contribution: Supporting study-related activities like protocol reviews, SAE reconciliation, and medical data reviews.
- Leadership and Mentorship: Leading CDM activities with internal and external teams while mentoring new team members.
- External Data Management: Coordinating data-related activities, including data from Central Labs, eCOA, and connected devices.
Qualifications
To excel in this role, you’ll need:
- Education: A bachelor’s degree or higher, preferably in life sciences or a drug development-related field.
- Experience: Hands-on experience in clinical data management, including at least one year in a project management role.
- Language Skills: Strong English proficiency, both verbal and written, to navigate global collaborations effectively.
Skills
The ideal candidate should possess:
- Technical Expertise: Knowledge of CDM and related regulations, including ICH E6 and E8.
- Project Management Abilities: Proven skills in managing timelines, coordinating teams, and delivering high-quality results.
- Soft Skills: Adaptability, quick learning, excellent interpersonal communication, and presentation skills.
- Quality Focus: A risk-based mindset emphasizing Quality by Design (QbD).
