Senior Specialist, External Data Acquisition and Delivery (EDAD)

Role & responsibilities

• Responsible for the development of new DTS templates in alignment with CDISC requirements. This includes:
• Authoring the DTS in collaboration with stakeholders, ensuring consistency and compliance with the applicable standard Data Transfer Specification templates and processes.
• Responding to external data providers and internal stakeholder queries to ensure data will be delivered are complete, in the correct format and structure.
• Tracking DTS status across different data types and programs. Ensure DTS development dates are met as per study timelines.
• Ensuring external data structure is consistent and compliant with appropriate standard Data Transfer Specification Templates.
• Supporting data structure issue resolution for assigned studies.
• Liaising cross functionally to facilitate the creation of new test codes.
• Processing change requests to update existing DTS for assigned studies.
• Support locking and archival of external data.
• Provide review of protocol requirements, vendor specifications, and operational data flows with minimal supervision.
• Maintenance of all Data Transfer Specification (DTS) documents, ensuring consistency and compliance with Regeneron standards, processes, templates, and timelines.
• Provide guidance on External Data Services to CROs, internal stakeholders, and external vendors across assigned data types.
• Monitor data trends to identify potential risks to data integrity or protocol deviations early in the study life cycle.
• Perform external data reconciliation activities between EDC and vendor data systems across all studies.

Preferred candidate profile

• Experience in managing multiple clinical data types and formats, e.g., biomarker, eCOA, imaging, ECG, PK, genomics, and laboratory data is required.
• Basic knowledge of database structures and protocol review as relevant to clinical data management is preferred.
• Demonstrates knowledge of all applicable regulations including 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards for data collection.
• Demonstrates basic knowledge of Data Management, External Data processes, and industry best practices.
• Proficiency and experience with extracting data into SAS, CSV, and XML formats is required.
• Knowledge of EDC platforms (e.g., Medidata Rave, Veeva, Oracle Inform, etc) and experience with external data reconciliation and query processes between EDC and vendor data systems.