Regeneron
Healthcare
AssociateDirector,ExternalDataAcquisitionandDelivery
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“Associate Director, External Data Acquisition and Delivery at Regeneron. Skills: External data acquisition, Data delivery strategy, Vendor management, Data quality. Lead External Data Acquisition. Lead data integration”
Industry & Context.
Problem-solving; Analytical skills
What They're Looking For.
Must Have
10+ years experience in Clinical Data Acquisition/Management, 4+ years people management experience, Experience overseeing external data reconciliation, Experience driving process improvements, Experience driving vendor oversight, Bachelor's degree in Science, Health, Mathematics, Computing, or Information Systems
Nice to Have
Advanced degree preferred
What You'll Do.
Lead External Data Acquisition
Lead data integration
Lead quality oversight
Lead delivery strategy
Serve as portfolio lead
Review protocol requirements
Review vendor specifications
Review operational data flows
Lead development of Data Transfer Specification (DTS) documents
Lead maintenance of Data Transfer Specification (DTS) documents
Provide expert mentorship on external data services
Drive external vendor oversight
Drive vendor onboarding
Drive vendor qualification
Drive vendor governance
Drive ongoing performance monitoring
Establish vendor KPIs
Establish vendor SLAs
Establish vendor quality metrics
Handle vendor quality metrics
Govern reconciliation activities
Monitor reconciliation metrics
Monitor discrepancy trends
Monitor resolution timelines
Collaborate to resolve data discrepancies
Lead process improvement initiatives
Lead automation opportunities
Lead implementation of innovative external data solutions
Support SOP development
Support inspection readiness
Support audit activities
Support regulatory compliance
Represent EDAD in leadership forums
Represent EDAD in governance committees
Represent EDAD in technology discussions
How You'll Work.
Team & Collaboration
Cross-functional partners; Clinical Data Management; CROs; External vendors; Database Development; Biostatistics; Study Data Managers
Communication Scope
Verbal communication; Written communication
Process & Methodology
Project management, Stakeholder management
Full Job Description
Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health. As an Associate Director, External Data Acquisition and Delivery (EDAD), you will provide strategic oversight and operational leadership for External Data Acquisition and Delivery activities across Regeneron’s clinical trial portfolio and initiatives. You will ensure readiness of external data collection platforms, data conformance tools, reconciliation processes, and the delivery of high-quality, compliant external data from third-party vendors including laboratory, biomarker, Digital Health Technologies, imaging, ECG, PK, genomics, and specialty data. You will partner closely with Clinical Data Management, CROs, external vendors, and cross-functional partners to drive external data strategy, operational excellence, vendor oversight, digital transformation initiatives, and process improvements. **A Typical Day May Include:** * Leading External Data Acquisition, integration, quality oversight, and delivery strategy across the clinical trial portfolio * Serving as a portfolio-level lead for external data quality and clinical-data operational strategy * Reviewing protocol requirements, vendor specifications, and operational data flows * Leading all aspects of development and maintenance of Data Transfer Specification (DTS) documents to ensure compliance with Regeneron standards and timelines * Providing expert mentorship on external data services including biomarker, eSource, eCOA, imaging, ECG, PK, genomics, and laboratory data * Driving external vendor oversight, onboarding, qualification, governance, and ongoing performance monitoring * Establis
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