Manager, Clinical Data Management – Study Lead

Regeneron

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

Posted 10/27/2026full-timeRemote • United StatesSenior💰 $114,800 - $187,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical data management, including oversight of data quality, database design, and compliance with regulatory standards. Proven ability to manage timelines, collaborate with cross-functional teams, and ensure successful execution of data management deliverables.

Highest-signal resume keywords

Clinical Data ManagementData Quality ReviewECRF and Database DesignOversight of CRO ActivitiesInspection Readiness Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data Management PlansSOP DevelopmentData Transfer ManagementMedDRA/WHO-DD CodingDatabase Locking ProceduresData Quality AssessmentRisk Identification and MitigationTimeline DevelopmentStatus ReportingDocumentation Oversight

Soft Skills

Problem-SolvingCollaborationCommunicationLeadershipEscalation Management

Industry Keywords

BiotechnologyPharmaceuticalHealth Related IndustryClinical TrialsCRO ManagementData Management StandardsRegulatory ComplianceQuality ReviewStudy Close-OutOperational Issues

About the role

Key responsibilities & impact

Provide oversight of lead Data Managers on assigned clinical data management studies
Assure planning and execution of data management deliverables according to Regeneron standards and timelines
Assist in developing SOPs, Working Practice, Data Management Plans, and other data management standards
Serve as DM study lead and primary contact for clinical study teams and external partners for one or more complex studies
Provide data management expertise and hands-on support related to eCRF and database design, data quality, and database/data quality status reporting
Oversee data quality review and data acceptance procedures before data analyses and/or database lock
Manage data transfers with CROs and third-party data sources, SAE/AE reconciliation, and MedDRA/WHO-DD coding
Support transfer, locking, and archiving of study databases
Manage scheduling and time constraints across multiple projects
Prepare recommendations for improved data management and data flow processes
Perform and document oversight of CRO data management activities
Ensure electronic case report forms, clinical trial databases, and electronic edit checks are designed, implemented, and maintained according to 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
Escalate issues and follow them through to resolution
Lead and oversee data management deliverables for assigned studies
Monitor data quality, remediation progress, risks, mitigations, and operational or vendor issues

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
Perform quality review and inspection readiness tasks to meet quarterly Inspection Readiness Review (IRR) compliance
Follow through on gaps until resolution, escalating as necessary
Experience overseeing data management deliverables for assigned studies
Ability to develop deliverable timelines according to business need and program objectives
Ability to develop snapshot/lock plans and collaborate with the CST for review and approval
Ability to provide regular status updates with metrics to CST
Ability to provide program-level input to and monitor deliverable timelines
Ability to monitor data quality and assess progress of data issue remediation
Ability to identify risks, propose mitigations, and proactively escalate operational, DM vendor, or DM CRO issues
Ability to travel as required, 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