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. Location: Swiftwater, PA.

Responsibilities

• Data governance and management: Maintain governance regarding clinical information from multiple data sources to provide exhaustive and accurate information for regulatory or non-regulatory requests (e.g., safety or regulatory reports such as DSUR, PBRER, NDA-AR) and for inspections or management requests.
• Internal collaboration and performance tracking: 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 across multiple entities and coordinate actions, including Medical, PSPVGPE, GRA, Clinical operations, HEOR/HEVA, pharmacovigilance, market access, and managed access programs; work closely 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 of combined professional experience in study management, regulatory/safety reporting, project management, and the 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 and written).
  • Power BI knowledge would be a plus.
• Professional Competencies:
  • Customer and quality focused; results-oriented with attention to detail.
  • Strong project management capabilities and transversal coordination.
  • Proven experience in matrix environments.
  • Effective communication and networking skills.
  • Team collaboration abilities and a demonstrated sense of urgency and proactivity.

Skills

• Data governance and management
• Stakeholder collaboration and cross-functional coordination
• Data quality assurance and regulatory/compliance tracking

Education

• Bachelor's Degree (accredited four-year college, university, or equivalent)