Senior Manager, Clinical Data Management, Study Lead

Regeneron Pharmaceuticals
•$134,400 - $219,200•Remote

About The Position

Regeneron is seeking a Senior Manager, Clinical Data Management, to join its Data Management team and support clinical studies across assigned therapeutic areas. This remote role leads clinical data management delivery and oversees a team of data managers, working with clinical study teams, CROs, and external data vendors. The position covers data management activities from study start-up through database lock and archiving, with responsibility for study oversight, data quality, compliance readiness, staff development, and process improvement.

Requirements

  • Bachelor’s degree in mathematics, science, or a related field.
  • At least 8 years of clinical data management experience in biotechnology, pharmaceutical, or a health-related industry.
  • Proven record of leading studies and study teams in a data processing environment.
  • Sophisticated knowledge of applicable regulations and standards, including 21 CFR Part 11, ICH-GCP, and CDISC.
  • Strong problem-solving, project management, and communication skills.
  • Ability to motivate virtual teams in a matrix environment.

Nice To Haves

  • At least 3 years of people management experience.
  • Certified Clinical Data Manager (CCDM) certification.

Responsibilities

  • Serve as the data management study lead and primary contact for study teams, CROs, and external data vendors across multiple trials.
  • Oversee data management activities from study start-up through database lock and archiving.
  • Provide sponsor oversight of CRO data management work, identifying gaps and driving them to resolution.
  • Review and approve key study documentation, including data management plans, CRF design, and data transfer specifications.
  • Maintain inspection readiness and eTMF documentation to meet quarterly compliance reviews.
  • Monitor data quality, deliverable timelines, and risks, and proactively call out issues.
  • Manage, coach, and develop data management staff, including recruitment and performance management.
  • Recommend process improvements, lead cross-functional initiatives, and act as a subject matter expert delivering training.

Benefits

  • Annual bonuses or other incentive plans, depending on country and role.
  • Equity awards, depending on country and role.
  • Pension or retirement benefits, depending on country and role.
  • 401(k) company match, depending on country and role.
  • Health and wellness programs, depending on country and role.
  • Fitness centers, depending on country and role.
  • Insurance benefits, including medical, dental, vision, life, and disability coverage, depending on country and role.
  • Paid time off, depending on country and role.
  • Family support benefits, depending on country and role.
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