Sanofi Group Global Study Manager in Bridgewater, New Jersey
Responsible for the conduct of studies ensuring adherence to FDA regulations, ICH GCP guidelines and SOPs/ Quality Documents
Solid Project Management background with the ability to manage all components of clinical trials from study outline/protocol through Clinical Study Report completion
Lead and coordinate clinical team members
Review and implement study protocols
Work with monitoring team or CRO to achieve optimum site selection and patient recruitment
Collaborate actively with data management to design eCRF, define data management plan and participate in data review
Create and review study training materials
Global study budget creation and ongoing budget management
Timeline planning and execution
Strong risk assessment and mitigation skills
Lead review of supplier Scope Of Works and ensure accuracy of clinical outsourcing vendor agreements including CRO, IRT, Central lab, eCOA, ECG and electronic data capture as well as manage vendors with respect to contracted scope of work and budget
Serve as liaison between clinical operations and other functional areas
Ability to collaborate effectively with cross-functional team members and external partners using collaborative negotiation skills
Proven stakeholder management skills (e.g. ability to manage expectations, challenge the status quo)
Minimum of 5 years of experience in managing clinical trials preferred
Degree in scientific discipline or equivalent RN
Experience working with international teams
Location: Bridgewater, NJ; Cambridge, MA—3 days on-site, 2 days home office
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.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
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.