Associate Director, External Data Acquisition and Delivery
Regeneron
August 22, 2026
Remote friendly (Warren, NJ)
United States
Operations
Associate Director, External Data Acquisition and Delivery (EDAD) — Clinical Data Management
Location/Work: Warren, NJ (Hybrid; 4 days/week on site). Travel up to 25%.
Responsibilities:
- Provide strategic oversight and operational leadership for external data acquisition and delivery across the clinical trial portfolio.
- Ensure readiness and delivery of compliant external data from third-party vendors (laboratory, biomarker, Digital Health Technologies, imaging, ECG, PK, genomics, specialty data).
- Lead external data quality/operational strategy; review protocol requirements, vendor specs, and data flows.
- Develop/maintain Data Transfer Specification (DTS) documents.
- Oversee vendor onboarding/qualification/governance; establish vendor KPIs/SLAs and quality metrics.
- Govern external data reconciliation between EDC systems and vendor platforms; monitor discrepancies and resolution timelines.
- Lead process improvements/automation and innovative external data solutions.
- Manage and develop EDAD team via coaching, mentoring, and performance management.
- Support SOP development, inspection readiness, audits, and regulatory compliance; represent EDAD in leadership/forums.
Qualifications (Required/Preferred):
- 10+ years clinical data acquisition/management in biotech/pharma/healthcare.
- 4+ years people management.
- Experience overseeing external data reconciliation (EDC to vendor platforms).
- Process improvement and vendor oversight experience.
- Bachelor’s degree in Science/Health/Math/Computing/Info Systems or related field. Advanced degree preferred.
- Expertise across multiple external data types (biomarker, eSource/eCOA, imaging, ECG, PK, genomics, lab, Digital Health Tech).
- Advanced knowledge of reconciliation and EDC platforms (e.g., Medidata Rave, Veeva, Oracle Inform).
- Experience with SAS, CSV, XML.
- Knowledge of 21 CFR Part 11, ICH-GCP, CDISC.
- Strong communication, project/stakeholder management, leadership, and ability to work in a matrixed global environment.
Compensation:
- Salary range (annual): $154,800.00 - $252,800.00.
Application:
- Apply now.
Location/Work: Warren, NJ (Hybrid; 4 days/week on site). Travel up to 25%.
Responsibilities:
- Provide strategic oversight and operational leadership for external data acquisition and delivery across the clinical trial portfolio.
- Ensure readiness and delivery of compliant external data from third-party vendors (laboratory, biomarker, Digital Health Technologies, imaging, ECG, PK, genomics, specialty data).
- Lead external data quality/operational strategy; review protocol requirements, vendor specs, and data flows.
- Develop/maintain Data Transfer Specification (DTS) documents.
- Oversee vendor onboarding/qualification/governance; establish vendor KPIs/SLAs and quality metrics.
- Govern external data reconciliation between EDC systems and vendor platforms; monitor discrepancies and resolution timelines.
- Lead process improvements/automation and innovative external data solutions.
- Manage and develop EDAD team via coaching, mentoring, and performance management.
- Support SOP development, inspection readiness, audits, and regulatory compliance; represent EDAD in leadership/forums.
Qualifications (Required/Preferred):
- 10+ years clinical data acquisition/management in biotech/pharma/healthcare.
- 4+ years people management.
- Experience overseeing external data reconciliation (EDC to vendor platforms).
- Process improvement and vendor oversight experience.
- Bachelor’s degree in Science/Health/Math/Computing/Info Systems or related field. Advanced degree preferred.
- Expertise across multiple external data types (biomarker, eSource/eCOA, imaging, ECG, PK, genomics, lab, Digital Health Tech).
- Advanced knowledge of reconciliation and EDC platforms (e.g., Medidata Rave, Veeva, Oracle Inform).
- Experience with SAS, CSV, XML.
- Knowledge of 21 CFR Part 11, ICH-GCP, CDISC.
- Strong communication, project/stakeholder management, leadership, and ability to work in a matrixed global environment.
Compensation:
- Salary range (annual): $154,800.00 - $252,800.00.
Application:
- Apply now.