Job Description:
Job Title: Global Study Data Leader
Location: Morristown, NJ
About the Job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
Global Study Data Leader is responsible for leading the end-to-end data management activities and associated quality deliverables for clinical trials including study set-up, conduct, and close-out, complying with GCP and applicable regulatory guidance.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities:
- Provide comprehensive data management expertise and support to team members.
- Coordinate cross functional teams globally to ensure the flawless conduct of a clinical trial.
- Ensure activities are completed according to agreed standards and timelines and serves as the Data Management representative in the study team.
About You
Requirements:
- 5+ years of experience in Clinical Data Management in the pharmaceutical industry (or equivalent) is required. 2+ years of project management experience in Data Management is required.
- Clinical Data Management System experience (CDMS) and understanding of
database/programming concepts.
- Understanding of industry standards, terminologies, (e.g., CDISC SDTM, MedDRA, etc.) current regulatory guidelines, and GCP practices regarding Data Management
- Vendor management
- Solid knowledge of the clinical trial development process
- Understanding of risk-based methodologies and regulations
- Experience using Data Visualization tools, e.g Spotfire, J-Review, Cluepoints preferred
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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
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