Regeneron
Healthcare
AssociateDirector,ExternalDataAcquisitionandDelivery
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“Associate Director, External Data Acquisition and Delivery at Regeneron. Skills: External data acquisition, External data delivery, Data quality oversight, Vendor management. Provide strategic oversight. Provide operational leadership”
Industry & Context.
Problem-solving skills
What They're Looking For.
Must Have
Minimum 10+ years experience in Clinical Data Acquisition/Management, Minimum 4+ years people management experience, Demonstrated experience overseeing external data reconciliation, Experience driving process improvements and vendor oversight, Bachelor's degree in Science, Health, Computing, or Information Systems
Nice to Have
Advanced degree preferred
What You'll Do.
Provide strategic oversight
Provide operational leadership
Ensure readiness of data collection platforms
Ensure readiness of data conformance tools
Ensure readiness of reconciliation processes
Ensure delivery of compliant external data
Partner with Clinical Data Management
Partner with external vendors
Partner with cross-functional partners
Drive external data strategy
Drive operational excellence
Drive vendor oversight
Drive digital transformation initiatives
Drive process improvements
Lead external data acquisition
Lead data integration
Lead quality oversight
Lead delivery strategy
Serve as portfolio-level lead
Review protocol requirements
Review vendor specifications
Review operational data flows
Lead development of DTS documents
Lead maintenance of DTS documents
Provide expert mentorship
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
Govern reconciliation activities
Monitor reconciliation metrics
Monitor discrepancy trends
Monitor resolution timelines
Collaborate with Database Development
Collaborate with Biostatistics
Collaborate with Study Data Managers
Collaborate with external vendors
Resolve complex data discrepancies
Lead process improvement initiatives
Lead automation opportunities
Lead implementation of innovative solutions
Manage team performance
Support SOP development
Support inspection readiness
Support audit activities
Support regulatory compliance
Represent EDAD in forums
Represent EDAD in committees
Represent EDAD in 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
Job Description **About Regeneron** 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. **This position is office-based and will be on site at Regeneron’s Hyderabad office.** **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 dat
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