Principal Specialist, Clinical Data Management

Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis
* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science.

For more information, visit , and follow the company on Linked In, X, Facebook and You Tube. (
* in collaboration with Abb Vie)

Leads, performs, and oversees data management activities for assigned clinical studies for both in-house and outsourced clinical trial data; evaluates, develops, and implements data management processes, procedures, and tools to ensure business requirements are met; collaborates within Biometrics and with Medical, DSPV, Regulatory, QC, and other internal customers to ensure high quality data in support of regulatory submissions, safety reporting, and publications.

• Leads, performs, and oversees data management activities for clinical studies and/or clinical programs
• Performs hands‑on clinical data management tasks to support clinical studies, including, but not limited to: reviewing study protocols, designing eCRFs, performing and coordinating user acceptance testing (UAT), documenting edit check specifications, QC’ing external data transfers, performing data quality checks/discrepancy review, and ensuring database lock activities are completed
• Participates in, reviews, and leads development of policies, Standard Operating Procedures (SOPs), processes, and associated documents for data management; provides input on SOPs and processes in which data management is involved
• Promotes/advocates data management at inter‑ and intradepartmental meetings
• Provides technical expertise to staff within Data Management, Biometrics, and other NBI departments; develops and executes training, including project‑specific training, as necessary
• Assists with responding to questions and findings from QA audits; ensures responses to Corrective Action Forms (CAFs) are closed out appropriately
• Actively researches current industry trends and shares information with appropriate individuals at NBI
• Recommends improvements to existing data management practices and procedures, including identifying, recommending, and implementing solutions for technology issues
• Assists in the development of standardized documents within data management (both within and across projects/programs), including electronic case report forms and edit checks
• Oversees screening, selection, validation, and implementation of data management software purchases and upgrades
• Participates in selecting outsourcing vendors and reviews data management sections of proposals, including scope of work; monitors budgets as appropriate
• Coordinates data management timelines for individual projects and well as clinical programs, including database lock, DSMB meetings, data review meetings, and monitoring CRO performance of data management tasks to ensure that timelines are met and…