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Regeneron

Manager, Clinical Data Management Study Lead

Regeneron

. Provide oversight of lead Data Managers on assigned clinical data management studies .

Posted 9/29/2026full-timeRemote • United StatesSenior💰 $114,800 - $187,400 per yearWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in clinical data management, overseeing data quality, eCRF and database design, and managing data transfers with CROs. Proven ability to develop timelines, monitor data quality, and ensure compliance with SOPs and WIs.

Highest-signal resume keywords
Clinical Data Management ExpertiseECRF And Database DesignData Quality ReviewSAE/AE ReconciliationQuality Review And Inspection Readiness

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Clinical Data ManagementECRF DesignDatabase DesignData Quality ReportingData Transfer ManagementMedDRA CodingWHO-DD CodingData Acceptance ProceduresSnapshot/Lock PlansMetrics Development
Soft Skills
Problem SolvingRisk IdentificationCommunicationProject ManagementCollaboration
Tools & Technologies
Clinical Trial DatabasesElectronic Edit Checks
Industry Keywords
BiotechnologyPharmaceuticalHealth Related IndustryCRO ManagementCompliance

About the role

Key responsibilities & impact
  • Provide oversight of lead Data Managers on assigned clinical data management studies
  • Serve as DM study lead and primary point of contact for clinical study teams, external data vendors, and CROs
  • Oversee data management activities from study start-up through archiving
  • Provide data management expertise and hands-on support related to eCRF and database design, data quality, and reporting
  • Oversee data quality review and data acceptance procedures before data analyses and/or database lock
  • Manage data transfers, SAE/AE reconciliation, and MedDRA/WHO-DD coding
  • Support study database transfer, locking, and archiving
  • Manage scheduling and time constraints across multiple projects
  • Prepare recommendations for improved data management processes and data flow
  • Oversee CRO data management activities and ensure eCRF, clinical trial database, and electronic edit check execution follows SOPs and WIs
  • Identify data quality, CRO performance, documentation, and process execution gaps and ensure resolution
  • Document sponsor oversight from protocol review through study close-out
  • Review and approve study documentation
  • Perform quality review and inspection readiness tasks for quarterly IRR compliance
  • Lead and oversee data management deliverables, timelines, snapshot/lock plans, status metrics, and program-level inputs
  • Monitor data quality and data issue remediation
  • Identify risks, propose mitigations, and proactively escalate operational, vendor, or CRO issues
  • Provide limited program-level support for small programs

Requirements

What you’ll need
  • Bachelor Degree or equivalent experience in Mathematics, Science or a related field
  • At least 7 or more years of clinical data management experience in biotechnology, pharmaceutical or health related industry
  • Expertise in clinical data management
  • Experience with eCRF and database design, data quality, and database/data quality status reporting
  • Experience with data quality review and data acceptance prior to data analyses and/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 with clinical trial databases and electronic edit checks
  • Quality review and inspection readiness experience
  • Ability to develop deliverable timelines, snapshot/lock plans, metrics, and status updates
  • Ability to monitor data quality, remediate data issues, identify risks, propose mitigations, and escalate operational or vendor/CRO issues
  • Ability to travel up to 25%

Benefits

Comp & perks
  • Annual bonuses or other incentive plans
  • Equity awards
  • Pension or retirement benefits
  • 401(k) company match
  • Health and wellness programs
  • Fitness centers
  • Medical, dental, vision, life and disability insurance benefits
  • Paid time off
  • Family support benefits
  • Reasonable accommodation during the recruitment process where required