Senior Specialist, External Data Acquisition and Delivery (EDAD)

Job description

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.