Job Title: Transversal Study Information Operations Manager
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.
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.
Why Choose Us?
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.
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Pursue progress , discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.
North America Applicants Only
The salary range for this position is:
$147.000,00 - $212.333,33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) .
Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
