Principal Specialist, Clinical Data Management

Role: Lead Data Management for clinical studies at Neurocrine Biosciences, focusing on ensuring high-quality, compliant data for regulatory, safety, and publication purposes. Responsibilities: oversee end-to-end data management activities, including protocol review, eCRF design, user acceptance testing, data QC, database lock, and vendor management; develop and improve data management SOPs and processes; collaborate with Biometrics, Medical, Regulatory, and QC teams; lead data review, coding, and standardization efforts (e.g., CDISC/SDTM); monitor project timelines, resource allocation, and CRO/vendor performance; participate in NDA submission activities; and mentor team members. Requirements: BS/BA in computer science or related field with 8+ years of industry experience, or advanced degrees with proportionally fewer years; 3+ years in a supervisory/lead role; strong knowledge of GxP, CDISC standards, Medidata Rave, and FDA guidelines; proficient in project management, data review, and programming tools (e.g., SAS, Business Objects). Preferred: experience with biologics or neurology indications, familiarity with electronic data capture systems, and cross-functional collaboration skills. High-Value: extensive clinical data management expertise in late-phase (Ph1-3 or post-market) neurological/psychiatric research, with an emphasis on regulatory compliance and process improvement. Work setup: not specified; likely hybrid or remote based on industry trends.