Transversal Study Information Operations Manager

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* Job Title:

** Transversal Study Information Operations Manager
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* Location:

** Swiftwater, PA
** About the Job
** 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.
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* Main 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…) 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.
* 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.
** About You
***
* 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.
* Bring the miracles of science to life alongside a supportive, future-focused team.
* Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
* Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
* Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race;

color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.#GD-SA    

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* progress*, discover
* extraordinary*Better is out there. Better medications, better outcomes, better science. But progress…