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 neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*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. Your Contributions (include, but are not limited to): 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 that any resource issues are identified and resolved Monitors in‑house resources of assigned projects and identifies potential deficiencies; works with supervisor to develop and implement a plan to overcome any obstacles Ensures that appropriate quality control checks and audit procedures are implemented according to department SOPs Runs data review listings, issues queries, codes Medical History and AE data using MedDRA dictionary and codes Concomitant Medications using WHO Drug dictionary Collaborates with database programmer to ensure NBI database standards, including CDISC/SDTM, are followed for both in‑house and, if appropriate, outsourced projects Identifies areas of risk and proactively communicates issues and solutions to supervisor and/or appropriate colleagues and team members Actively participates in data management‑related NDA submission activities, as appropriate Provides feedback, as requested, for performance evaluations Identifies strengths and areas for improvement for DM team members and works with supervisor to create a plan to develop team members Performs other duties as assigned Requirements: BS/BA degree in computer science or a related discipline AND 8+ years of experience in the Pharmaceutical Industry, (either in‑house/sponsor or CRO). Master’s degree in computer science or a related discipline AND 6+ years of similar experience noted above PhD in computer science or a related discipline AND 4+ years of similar experience noted above 3+ years of experience serving in a supervisory or lead capacity Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines Works to improve tools and processes within functional area Ability to work as part of and lead multiple teams Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams Excellent computer skills Excellent communication, problem‑solving, analytical thinking skills Sees broader picture, impact on multiple departments/divisions Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency Excellent project management skills Proficiency with Word, Excel, and PowerPoint is required Thorough understanding of the drug development process Proficiency with Medidata Rave is required Knowledge of other programming languages is a plus Familiarity with Business Objects and SAS is helpful Strong knowledge of Good Clinical Data Management Practices, CDISC/CDASH/SDTM and other FDA and industry‑standard guidelines is required Demonstrated proficiency in effectively overseeing/managing people (indirectly or directly) and organizing tasks is necessary

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Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description. The annual base salary we reasonably expect to pay is $130,800.00-$179,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits: retirement savings plan (with company match) paid vacation holiday and personal days paid caregiver/parental and medical leave health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans annual bonus with a target of 30% of the earned base salary eligibility to participate in our equity based long term incentive program We are a top place to work. Neurocrine Biosciences was named one of the FORTUNE Best Workplaces in Biopharma™ 2025. We were also named a Great Place to Work® Certified company. ©2025 Fortune Media IP Limited. All rights reserved. Used under license. OUR VALUES: PASSION: We are driven and love what we do. We are committed to our goals and to making a difference. INTEGRITY: We do the right thing for patients and our community. We take accountability. We speak up. COLLABORATION: We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed. INNOVATION: We seek and create optimal solutions. TENACITY: We do not quit. We adapt. We accomplish what others cannot. Come join our team during this exciting time of growth and opportunities! #J-18808-Ljbffr Neurocrine Biosciences