Regeneron
Regeneron
Regeneron is a biotechnology company that discovers, develops, and commercializes medicines for serious and underserved conditions. Its research spans allergy, cardiovascular and metabolic disease, neuroscience, oncology, hematology, ophthalmology, and rare diseases. By combining biological research with advanced technology, Regeneron works on biologics and genetic medicines designed to address complex healthcare needs. The company also highlights health equity, environmental responsibility, scientific education, and ethical corporate practices as part of its broader mission to advance patient care.

Clinical Data Management Study Lead Manager (Remote, U.S.) — Regeneron

Lead clinical data management for complex studies at Regeneron, overseeing data quality, CRO collaboration, database locking, and inspection readiness. The role combines study leadership with hands-on expertise in clinical data processes and deliverables.

Description

  • Oversee lead Data Managers across assigned clinical data management studies
  • Act as the data management study lead and main contact for study teams, external data vendors, and CROs
  • Direct data management activities from study initiation through archival
  • Provide practical data management guidance on eCRF and database design, data quality, and reporting
  • Oversee data quality reviews and data acceptance before analysis or database lock
  • Manage data transfers, SAE/AE reconciliation, and MedDRA/WHO-DD coding
  • Support study database transfers, locking, and archiving
  • Coordinate schedules and competing deadlines across multiple projects
  • Recommend improvements to data management processes and data flow
  • Oversee CRO data management work and confirm that eCRF, clinical trial database, and electronic edit check execution follows SOPs and WIs
  • Identify and resolve gaps in data quality, CRO performance, documentation, and process execution
  • Document sponsor oversight from protocol review through study close-out
  • Review and approve study documentation
  • Conduct quality reviews and inspection-readiness activities for quarterly IRR compliance
  • Lead data management deliverables, timelines, snapshot and lock plans, status metrics, and program-level inputs
  • Monitor data quality and remediation of data issues
  • Identify risks, develop mitigation proposals, and escalate operational, vendor, or CRO issues proactively
  • Provide limited data management support for small programs

Requirements

  • Bachelor’s degree or equivalent experience in mathematics, science, or a related discipline
  • Seven or more years of clinical data management experience in the biotechnology, pharmaceutical, or health-related industry
  • Advanced expertise in clinical data management
  • Experience designing eCRFs and databases and reporting data quality and database status
  • Experience reviewing data quality and accepting data before analysis or database lock
  • Experience managing data transfers with CROs and third-party data sources
  • Experience with SAE/AE reconciliation and MedDRA/WHO-DD coding
  • Experience working with clinical trial databases and electronic edit checks
  • Experience conducting quality reviews and supporting inspection readiness
  • Ability to create deliverable schedules, snapshot and lock plans, metrics, and status updates
  • Ability to monitor data quality, resolve data issues, identify risks, propose mitigations, and escalate operational or vendor/CRO concerns
  • Ability to travel up to 25%

Benefits

  • Annual bonus or other incentive opportunities
  • Equity awards
  • Pension or retirement benefits
  • Company-matched 401(k)
  • Health and wellness programs
  • On-site fitness centers
  • Medical, dental, vision, life, and disability insurance
  • Paid time off
  • Family support benefits
  • Reasonable recruitment-process accommodations when required

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