Jobs · Analyst · New Jersey

Clinical Data Lead (Data Manager)

BioSpace · Morristown, NJ · 5 days ago
On-siteAnalystFull-time

In the scope of clinical development of our products, the Clinical Data Lead adapts and coordinates the data management strategy during development and conduct of clinical studies/projects. They ensure integrity of data and appropriate level of quality for each assigned clinical study to deliver a cleaned and accurate clinical database, allowing its statistical analysis and submission. This role acts as the Clinical Data Management (CDM) referent within the clinical team and with other departments or external partners.

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. Our teams explore new technologies to protect people and promote healthy communities, pursuing progress to make a real impact on millions of patients worldwide.

Responsibilities

  • Plan and coordinate data management activities in line with standards and regulations.
  • Ensure oversight of external vendors/partners as applicable.
  • Represent Clinical Data Management (CDM) with the Clinical Team and other departments (Digital, Pharmacovigilance, Labs) or external parties.
  • Perform and/or ensure oversight of processes to achieve the required level of database quality, respecting timelines, documentation, and readiness for audit and inspection.
  • Contribute to the improvement of global data management processes by providing business expertise and project management skills.
  • Cooperate transversally within Sanofi with various partners.

Requirements

  • Bachelor's degree in Health/Life Sciences, Technical Sciences, or a related scientific field.
  • A minimum of 3+ years of experience in data management within the clinical or medical field.

Skills

  • Proficiency in data management software including Rave, EDC systems, and eCOA platforms, as well as SAS and data visualization tools.
  • Solid understanding of clinical/medical field standards and regulations.
  • Project management capabilities and experience in outsourcing oversight.
  • Full professional proficiency in English; French is considered an asset.

Benefits

  • Opportunities for career growth through promotions, lateral moves, or international assignments.
  • A comprehensive rewards package recognizing your contributions and amplifying your impact.
  • Health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks' gender-neutral parental leave.
  • Work at the forefront of AI-driven research, smart manufacturing, and groundbreaking mRNA platforms.
  • Contribute to protecting half a billion people annually through global vaccination efforts.
  • Access to mentoring, international mobility programs, and career development opportunities across four continents.

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