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Sanofi Group Lead Global Study Manager in Bridgewater, New Jersey

Job details:

  • The Global Study Manager (GSM) is responsible for the operational planning, management & execution of clinical study and program(s) w/in Trial Operations. The GSM is the leader of the clinical study team and empowered to drive the management & delivery of the study team operational objectives , ensuring all trial deliverables are met according to the study timelines, within budget and having the highest quality standards (GCP / ICH, SOPs / QDs).

  • The GSM leads the preparation of study related plans and materials, identification of study risks and contingency planning, appropriate escalation of issues, monitors the study planning, manages budget to ensure it is kept within budget and leads the execution of the study with integrity and suitable for regulatory review.

  • The GSM leads cross-functional study teams: responsible for the coordination of internal/ external resources, organization of internal team meetings, s/he drives and oversees vendors for the flawless execution of studies. Responsible for management of Clinical and Medical Service Providers, set up & oversight of service providers and ensure adherence to scope of work within timelines and budget.

  • The scope of this position requires an excellent communication skills (written and oral), a critical-thinking/ problem solving mindset and string leadership to manage across functions and to drive the operational success of study activities.

Formal Education And Experience Required:

  • Bachelor's degree (advanced degree preferred) plus a min of 5 years of experience in managing clinical trials.

Knowledge And Skills Desirable But Not Essential:

  • Degree in scientific discipline or equivalent RN preferred PMP certification (optional)

  • Experience of working internationally

  • Experience of anticipating and resolving problems

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.

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.

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