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, whereby Sanofi can have internal and external obligations or commitments for providing organized study information. This role collaborates with stakeholders in Medical, PSPV, RWE, Quality, Digital, and reporting teams.

• Data Governance and Management:
  Responsible for maintaining governance regarding clinical information from multiple data sources (Sanofi tracking systems) to provide business entities that manage studies access to exhaustive and accurate information. This includes documents, for regulatory or non-regulatory requests (e.g., preparation of safety or regulatory reports such as DSUR, PBRER, NDA-AR etc.), expected or unexpected (inspections, management request etc…) purposes. This will also apply to other entities managing external reporting obligations.
• Interaction with internal operational teams to ensure data quality and consistency within tracking systems and clinical document repositories is implemented.
• Track and communicate performance/compliance indicators to support business needs.
• Stakeholder
  
  Collaboration:
  
  Develop and maintain interactions with key stakeholders, including PSPVGPE, GRA, Medical and Clinical trial disclosure teams;
  Clinical operations (global and local);
  Medical GBUs; HEOR HEVA;
  Pharmacoepidemiology;
  Market access teams;
  Managed access programs;
  Coordinate actions across multiple entities;
  Work closely with Sanofi Business Operations for Real World Evidence processes.

• 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.

• 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.

• 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.