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Regeneron Pharmaceuticals2 weeks ago

Senior Manager, Clinical Data Management

$134,400–$219,200 year

Remote · United States

Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Enterprise

Job Summary

Senior Manager, Clinical Data Management leads data management activities across studies from start-up to archiving, serving as primary contact for study teams, CROs, and vendors. Oversees data quality review, acceptance, and database lock processes; manages data transfers, coding, and reconciliation across systems; reviews study documentation including data plans and specifications; ensures inspection readiness and maintains compliant documentation in eTMF. Collaborates across cross-functional and external teams, prioritizes multiple activities with strong attention to detail. Requires a Bachelor’s degree in Mathematics, Science, or related field, 8+ years of clinical data management experience, knowledge of 21 CFR Part 11 and ICH-GCP, CCDM certification, and demonstrated leadership and people management experience. Salary range provided for U.S. roles and benefits described; remote work option noted as Remote US with some on-site considerations per location policy.

Required Qualifications

  • Bachelor’s degree in Mathematics, Science, or related field
  • Minimum 8+ years of clinical data management experience
  • Knowledge of 21 CFR Part 11 and ICH-GCP
  • Experience leading studies and data management teams
  • Strong understanding of data management processes and industry standards
  • CCDM certification
  • People management and team development
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$134k – $219k / yr

Senior Manager, Clinical Data Management · Regeneron Pharmaceuticals

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