JOB PURPOSE:

　　In the scope of clinical development of our products, the incumbent's mission is to adapt and coordinate the data management strategy during development and conduct of clinical studies/projects including mRNA projects/studies. The Clinical Data Lead 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. The Clinical Data Lead also acts as Clinical Data Management (CDM) referent within the clinical team and with other departments or external partners, as well as contributes to the optimization of Data Management process as well as maintenance and evolution of Data Management in Digital environment.

　　This position is based in the Swiftwater, PA office. The ideal candidate will live within a reasonable (2 hour) commute, or be willing to relocate at their own expense.

　　KEY ACCOUNTABILITIES:

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

　　Ensure the oversight of external vendors/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.

　　Requirements & Qualifications:

　　Bachelor's degree in Health/Life Science, Technical Sciences or other related area

　　Skills and Experience in data management in clinical/medical field and lab data (minimum 5 years)

　　Knowledge of data management software and computing skills (e.g., Rave, EDC systems, eCOA, SAS, Data visualization, RBM Tool) highly preferred.

　　Project management skills/experience highly preferred, experience with MS Project preferred as well

　　Technical writing experience preferred

　　Knowledge in outsourcing oversight.

　　Skills:

　　Fluent in English. French notion would be appreciated.

　　Ability to work in a multi-cultural environment.

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

　　Ability to network and communicate with various functions.

　　Analytical, process-oriented with interest to drive continuous improvements.

　　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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　　At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.