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Transversal Study Information Operations Manager

Sanofi
Remote friendly (Cambridge, MA)
United States
Operations

Role Summary

The Transversal Study Information Operations Manager oversees operational strategies for identifying, tracking, and internal communication of human data collection and analytics across Sanofi's international, regional, and local obligations. The role ensures organized study information for internal and external reporting and collaborates with stakeholders in Medical, PSPV, RWE, Quality, Digital, and reporting teams. Location: Swiftwater, PA.

Responsibilities

  • Data Governance and Management
    • Maintain governance of clinical information from multiple data sources to provide exhaustive and accurate information for internal study management and for regulatory or non-regulatory requests (e.g., safety or regulatory reports such as DSUR, PBRER, NDA-AR) and other external reporting obligations.
    • Interact with internal operational teams to ensure data quality and consistency within tracking systems and clinical document repositories.
    • Track and communicate performance and compliance indicators to support business needs.
  • Stakeholder Collaboration
    • Develop and maintain interactions with key stakeholders including PSPVGPE, GRA, Medical and Clinical trial disclosure teams.
    • Coordinate actions across multiple entities and work closely with Sanofi Business Operations for Real World Evidence processes.

Qualifications

  • 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

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)