Principal Specialist, Clinical Data Mgmt

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, 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 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 neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)

About the Role:

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.

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Your Contributions (include, but are not limited to):

• Leads, performs, and oversees data management activities for clinical studies and/or clinical programs

• Experience leading and supporting First-In-Human (FIH) clinical studies, including early protocol review, eCRF and database design, and alignment with dose-escalation and safety objectives

• Hands-on management of data management activities for FIH studies, with emphasis on rapid data cleaning, near real-time safety data review, and support for frequent interim analyses

• Close collaboration with Clinical Operations, Safety, and Biostatistics teams to support timely decision-making and governance in FIH studies

• 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

• Participate in, review, and lead development of policies, Standard Operating Procedures (SOPs), processes, and associated documents for data management; provide input on SOPs and processes in which data management is involved

• Promote/advocate data management at inter- and intradepartmental meetings

• Provide technical expertise to staff within Data Management, Biometrics, and other NBI departments; develop and execute training, including project-specific training, as necessary

• Assist with responding to ques