Senior Specialist, External Data Acquisition and Delivery
Core
Manage end-to-end non-Case Report Form data across assigned studies, developing Data Transfer Specifications, performing external data reconciliation, and ensuring accurate vendor data transfer and cleaning.
Role type
Senior Specialist, Clinical Data Management (External Data Acquisition)
Builds
Clinical study data packages for drug development programs
Domain
Biotechnology / Pharmaceutical / Clinical Data Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Data Transfer Specifications (DTS) development, external data reconciliation, CDISC standards, EDC platform management, data extraction (SAS/CSV/XML), protocol review, vendor management, regulatory compliance (21 CFR Part 11, ICH-GCP)
Preferred skills
Database structure knowledge, process improvement, strategic thinking
Technologies
Medidata Rave, Veeva, Oracle Inform, SAS, CSV, XML
Responsibilities
Develop and maintain Data Transfer Specifications (DTS) for assigned studies; Act as primary technical point of contact between clinical data management and vendors; Reconcile external vendor data against clinical database; Process change requests and support data structure issue resolution; Track DTS status and milestones; Support data locking, archival, and inspection readiness standards.
Seniority
Senior, hands-on IC
