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 ensures organized study information for internal and external obligations or commitments and collaborates with stakeholders in Medical, PSPV, RWE, Quality, Digital, and reporting teams. Location: Swiftwater, PA.

Responsibilities

• 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…), and other external reporting obligations.
• Interaction with internal operational teams to ensure data quality and consistency within tracking systems and clinical document repositories.
• 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.
• Health Economic Outcome Research (HEOR) Health Economics and Value Assessment (HEVA).
• Pharmacoepidemiology.
• Market access teams.
• Managed access programs.
• Coordinate actions across multiple entities.
• Work closely with Sanofi Business Operations for Real World Evidence processes.

Qualifications

• Minimum 10 Years Combined Professional Experience In:
  • Study management
  • Regulatory/safety reporting
  • Project management
  • Pharmaceutical industry

Skills

• 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

Education

• Bachelor's Degree (accredited four-year College, University, or equivalent)