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 dedicated to discovering and developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders. Our portfolio includes FDA-approved treatments for conditions such as tardive dyskinesia, Huntington's chorea, congenital adrenal hyperplasia, endometriosis, and uterine fibroids, along with a pipeline of compounds in clinical development. We leverage our neuroscience expertise to create medicines that ease the burden of debilitating diseases. For more information, visit neurocrine.com and follow us on LinkedIn, X, and Facebook. ( *in collaboration with AbbVie ) About the Role: Leads and oversees data management activities for clinical studies, ensuring high-quality data to support regulatory submissions, safety reporting, and publications. Collaborates across departments to develop and implement data management processes, procedures, and tools. Your Contributions (include, but are not limited to): Lead and perform data management activities for clinical studies and programs. Support clinical studies with tasks such as reviewing protocols, designing eCRFs, UAT, documenting specifications, QC, and database lock activities. Develop and review policies, SOPs, and processes related to data management. Promote data management practices within and outside the department. Provide technical expertise, training, and support to staff. Respond to QA audits and ensure corrective actions are completed. Research industry trends and recommend improvements. Oversee software selection and upgrades. Participate in vendor selection and review proposals. Coordinate project timelines, monitor resources, and ensure quality control. Run data reviews, issue queries, and code data using MedDRA and WHO Drug dictionaries. Ensure database standards (CDISC/SDTM) are followed. Identify risks and communicate issues proactively. Support NDA submissions and performance evaluations. Perform other duties as assigned. Requirements: BS/BA in computer science or related field with 8+ years of industry experience, or Master's degree with 6+ years of experience, or PhD with 4+ years of experience and 3+ years in a supervisory role. Additional qualifications include knowledge of best practices, leadership skills, proficiency in relevant software (Word, Excel, PowerPoint, Medidata Rave), understanding of drug development, and familiarity with industry standards and guidelines. Neurocrine Biosciences is an EEO/Disability/Vets employer committed to diversity and inclusion. We offer competitive salaries, bonuses, benefits, and a supportive work environment. #J-18808-Ljbffr Neurocrine Biosciences
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