Associate Director, Clinical Data Management

Neurocrine Biosciences, Inc.; California; On-site; USD 130,000 - 210,000; Full time

Job summary

Neurocrine Biosciences, Inc. is seeking a leader to provide operational leadership for clinical data management across assigned studies and programs, delivering high-quality, inspection-ready data to support development, regulatory submissions, and decision-making.

You will oversee data collection strategy, EDC/database builds, data reviews, reconciliation, database lock readiness, and vendor oversight, collaborating with Biostatistics, Medical, Safety, Regulatory, and external partners to

Responsibilities

• Leads clinical data management activities across assigned studies and/or programs to ensure accurate, complete, timely, high-quality, and inspection-ready clinical trial data deliverables
• Provides operational leadership across the clinical data lifecycle, including data collection strategy, EDC/database build, external data integration, data review, reconciliation, database lock readiness, and clinical data delivery within assigned scope
• Leads development and execution of key CDM deliverables, including data management plans, data review plans, database specifications, edit check specifications, query management processes, quality review activities, database audits, and database lock plans
• Leads or contribute to technology enablement and modernization efforts within assigned scope, including scalable EDC build approaches, standard libraries, reusable CRFs/edit checks, automation, AI-enabled data review workflows, and solutions that support end-to-end biometrics standardization
• Partners with Biostatistics and Statistical Programming to support end-to-end traceability from protocol and CRF design through SDTM-ready and analysis-ready data, reducing downstream rework and improving analysis timelines
• Monitors CDM metrics, dashboards, and operational reports to track data quality, query trends, vendor performance, cycle times, reconciliation status, lock readiness, and milestone achievement for assigned studies/programs
• Leads identification, escalation, and resolution of complex CDM issues within assigned scope, including data quality trends, database discrepancies, external data reconciliation challenges, vendor performance concerns, and cross-functional process risks
• Directs CROs, vendors, contractors, and other external partners supporting assigned CDM activities; monitor performance, deliverables, quality, timelines, issue resolution, and compliance with contractual and regulatory expectations
• Represents CDM in study team, program team, vendor, and operational meetings; communicate risks, recommendations, decisions, and progress to CDM leadership and cross-functional stakeholders
• Partners with Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety/PV, Regulatory, Quality, Clinical Systems/IT, and external vendors to align CDM activities with study timelines, regulatory expectations, program goals, and business needs
• Recommends development and improvement of CDM processes, standards, templates, work practices, and governance mechanisms to increase operational efficiency, inspection readiness, quality, and consistency across studies and programs
• Ensures CDM activities are conducted in accordance with applicable regulations, Good Clinical Practice, ICH guidelines, Good Clinical Data Management Practices, SOPs, work instructions, data integrity expectations, and study-specifi

Job description

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 )

At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what's ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.

About the Role:

Provides operational leadership for clinical data management activities across assigned clinical studies and programs to deliver high-quality, inspection-ready clinical data in support of clinical development, regulatory submissions, and business decision-making. Accountable for execution quality across the clinical data lifecycle within assigned scope, including data collection strategy, EDC/database build, external data integration, data review, reconciliation, database lock readiness, and vendor oversight.

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

• Leads clinical data management activities across assigned studies and/or programs to ensure accurate, complete, timely, high-quality, and inspection-ready clinical trial data deliverables
• Provides operational leadership across the clinical data lifecycle, including data collection strategy, EDC/database build, external data integration, data review, reconciliation, database lock readiness, and clinical data delivery within assigned scope
• Leads development and execution of key CDM deliverables, including data management plans, data review plans, database specifications, edit check specifications, query management processes, quality review activities, database audits, and database lock plans
• Leads or contribute to technology enablement and modernization efforts within assigned scope, including scalable EDC build approaches, standard libraries, reusable CRFs/edit checks, automation, AI-enabled data review workflows, and solutions that support end-to-end biometrics standardization
• Partners with Biostatistics and Statistical Programming to support end-to-end traceability from protocol and CRF design through SDTM-ready and analysis-ready data, reducing downstream rework and improving analysis timelines
• Monitors CDM metrics, dashboards, and operational reports to track data quality, query trends, vendor performance, cycle times, reconciliation status, lock readiness, and milestone achievement for assigned studies/programs
• Leads identification, escalation, and resolution of complex CDM issues within assigned scope, including data quality trends, database discrepancies, external data reconciliation challenges, vendor performance concerns, and cross-functional process risks
• Directs CROs, vendors, contractors, and other external partners supporting assigned CDM activities; monitor performance, deliverables, quality, timelines, issue resolution, and compliance with contractual and regulatory expectations
• Represents CDM in study team, program team, vendor, and operational meetings; communicate risks, recommendations, decisions, and progress to CDM leadership and cross-functional stakeholders
• Partners with Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety/PV, Regulatory, Quality, Clinical Systems/IT, and external vendors to align CDM activities with study timelines, regulatory expectations, program goals, and business needs
• Recommends development and improvement of CDM processes, standards, templates, work practices, and governance mechanisms to increase operational efficiency, inspection readiness, quality, and consistency across studies and programs
• Ensures CDM activities are conducted in accordance with applicable regulations, Good Clinical Practice, ICH guidelines, Good Clinical Data Management Practices, SOPs, work instructions, data integrity expectations, and study-specifi