Principal Specialist, Clinical Data Management

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:

The Principal Specialist, Clinical Data Management is responsible for overseeing the clinical database programming function within Clinical Data Management for all Neurocrine studies.

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

• Train, supervise, evaluate, and mentor/develop clinical database programmers in order to support the creation and maintenance of clinical study databases for all corporate therapeutic program areas

• Work with head of Data Management and project team to develop and monitor database-related timelines such as database set-up, validation procedure programming, and timing of batch data transfers

• Evaluate current processes; set standards and ensure consistency within and across programs and studies

• Set priorities and ensure alignment with company objectives

• Oversee quality of work performed and ensure it meets Neurocrine-defined standards

• Oversee electronic data loading (set specifications with external vendors, monitor timelines, load data); update/install new coding dictionary versions; actively participate in installation, validation and implementation of new software

• Develop required SOPs and work instructions as well as Data Management Plan documents; ensure processes are followed and all work is documented per SOPs

• Ensure process efficiency, proactively identify any gaps, and work with staff to implement alternative processes as necessary

• Analyze problems of high complexity; develop and implement alternative solutions both internally and with vendors; proactively identify areas of inconsistency and processes for potential improvement

• Serve as the expert resource for clinical database programming within the clinical data management group, within and outside of Biometrics; acts as a liaison between Clinical Data Management and project teams as needed

• Perform clinical database programming tasks, including, but not limited to,