Transversal Study Information Operations Manager

Role Summary

The Transversal Study Information Operations Manager oversees operational strategies for the identification, tracking, and internal communication of human data collection and analytics across Sanofi's international, regional, and local obligations. This role collaborates with stakeholders in Medical, PSPV, RWE, Quality, Digital, and reporting teams.

Responsibilities

• Data Governance and Management: maintain governance regarding clinical information from multiple data sources to provide access to exhaustive and accurate information for studies, including documents for regulatory or non-regulatory requests (e.g., safety/regulatory reports such as DSUR, PBRER, NDA-AR), inspections, or management requests.
• Ensure data quality and consistency within tracking systems and clinical document repositories; interact with internal operational teams to implement governance.
• Track and communicate performance and compliance indicators to support business needs.
• Stakeholder Collaboration: develop and maintain interactions with key stakeholders (PSPVGPE, GRA, Medical and Clinical trial disclosure teams, Clinical operations, Medical GBUs, HEOR/HEVA, Pharmacoepidemiology, Market access, Managed access programs); coordinate actions across multiple entities; work with Sanofi Business Operations for Real World Evidence processes.

Qualifications

Education And Experience

• Bachelor's Degree (accredited four-year college, university, or equivalent).
• Minimum 10 years combined professional experience in:
  • Study management
  • Regulatory/safety reporting
  • Project management
  • Pharmaceutical industry

Technical Skills

• Scientific or digital background
• Proficiency with databases and data management tools
• Understanding of data flow and tracking systems
• Fluent English (oral & written)
• Power BI knowledge would be a plus

Professional Competencies

• Customer and quality-focused / results-oriented with attention to detail
• Strong project management capabilities / transversal coordination
• Proven experience in matrix environments
• Effective communication and networking skills
• Team collaboration abilities
• Demonstrated sense of urgency and proactivity