Clinical Data Lead - Vaccines

Job Title: Clinical Data Lead - Vaccines

Location: Morristown, NJ

About the Job

The Clinical Data Lead adapts and coordinates the data management strategy during development and conduct of clinical studies/projects for the mRNA/vaccine team within Sanofi. In addition, the Clinical Data Lead ensures data integrity and quality for clinical studies in order to deliver a comprehensive clinical database, and contributes to the optimization of data management processes and innovations.
 

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

• Plan and coordinate the development and conduct of clinical trial activities in the scope of outsourcing, with internal contacts and external partners

• Ensures integrity of data and appropriate level of quality for each clinical study in order to deliver a cleaned and accurate clinical database, allowing its statistical analysis and submission.

• Acts as Clinical Data Management (CDM) referent within the clinical team and with other departments or external partners.

• Contributes to the optimization of Data Management process as well as maintenance and evolution of Data Management in Digital environment.

• Ensure the oversight of external vendors and partners

• Represent CDM with Clinical Team and other departments (Digital, PV, Labs) or external parties

• Manage all steps of clinical study, in line with Standards and Regulations

• Perform and/or ensure oversight of the processes allowing to reach the required level of quality of database until its lock in the best conditions of reliability, respect of timelines, documentation and readiness for audit and inspection

• Contribute to improvement of global data management process through working groups, cross-functional initiatives or involvement in technical projects by providing business expertise and project management skills

• Cooperate transversally within Sanofi with various partners

About You

• Earned Bachelor's Degree in Health/Life Science, Technical Sciences or other related area

• Three (3) years experience in data management in clinical/medical field, with additional experience with lab data preferred

• Knowledge of electronic data management software and computing skills (e.g., Rave, EDC systems, eCOA, SAS, Data visualization, RBM Tool) is required

• Project management skills (use of MS Project is helpful) are essential

• Experience with outsourcing oversight

• Knowledge of vaccine landscape is ideal but not required

• Ability to work in a global environment and with other global teams

• Team spirit, active listening, ability to contribute or lead working groups

• Ability to network and communicate with various functions

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 and check out our Diversity Equity and Inclusion actions at sanofi.com!

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:

$108,750.00 - $157,083.33

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.