Associate Director, Clinical Data Management

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $171.8k - $235k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

🦅 H1B Visa Sponsor

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Neurocrine Biosciences

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. 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, 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.

📋 Description

• Lead clinical data management activities across assigned studies and/or programs to ensure accurate, complete, timely, high-quality, and inspection-ready clinical trial data deliverables • Provide 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 • Lead development and execution of CDM deliverables, including data management plans, data review plans, database specifications, edit check specifications, query management processes, quality reviews, database audits, and database lock plans • Lead or contribute to technology enablement and modernization efforts, including scalable EDC builds, standard libraries, reusable CRFs/edit checks, automation, AI-enabled data review workflows, and biometrics standardization • Partner with Biostatistics and Statistical Programming to support traceability from protocol and CRF design through SDTM-ready and analysis-ready data • Monitor CDM metrics, dashboards, and operational reports for data quality, query trends, vendor performance, cycle times, reconciliation status, lock readiness, and milestone achievement • Identify, escalate, and resolve complex CDM issues, including data quality trends, database discrepancies, external data reconciliation challenges, vendor performance concerns, and cross-functional process risks • Direct CROs, vendors, contractors, and external partners; monitor performance, deliverables, quality, timelines, issue resolution, and compliance • Represent CDM in study team, program team, vendor, and operational meetings; communicate risks, recommendations, decisions, and progress • Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety/PV, Regulatory, Quality, Clinical Systems/IT, and external vendors • Recommend improvements to CDM processes, standards, templates, work practices, and governance mechanisms • Ensure compliance with regulations, Good Clinical Practice, ICH guidelines, Good Clinical Data Management Practices, SOPs, work instructions, data integrity expectations, and study-specific requirements • Support CDM-related inspections, audits, quality reviews, data integrity initiatives, and corrective/preventive actions • Provide coaching, performance feedback, and development support to CDM employees, contractors, and matrixed team members • Contribute to resource planning, vendor proposal review, staffing needs assessment, timeline planning, and capability development • Provide input into protocol design, CRF design, data standards, endpoint implementation, and cross-study consistency • Monitor industry trends, technologies, data standards, and evolving regulatory expectations; recommend process or system improvements • Perform other duties as assigned

🎯 Requirements

• BS/BA Degree in Computer Science, Life and Science related field and 10+ years of experience in Clinical Data Management in a biopharmaceutical setting, or Master's Degree in Computer Science, Life and Science related field and 8+ years of similar experience, or PhD and 6+ years of similar experience • Strong experience leading Clinical Data Management activities across multiple clinical studies and/or programs in biotechnology, pharmaceutical, or CRO environments • Strong knowledge of the clinical data lifecycle, including data collection strategy, CRF design, EDC/database build, external data integration, data review, reconciliation, database lock, and clinical data delivery • Working knowledge of EDC platforms and related CDM systems; Medidata Rave experience preferred • Experience with clinical data standards, including CDASH, SDTM, controlled terminology, standard CRF libraries, and cross-study standardization • Demonstrated ability to partner with Biostatistics and Statistical Programming to support fit-for-purpose data collection, end-to-end traceability, and analysis-ready data • Experience overseeing CROs, vendors, contractors, and external data providers in outsourced or hybrid operating models • Knowledge of GCP, ICH guidelines, regulatory expectations, data integrity principles, SOPs, and inspection-readiness requirements • Experience using CDM metrics and dashboards to monitor quality, predictability, vendor performance, and database lock readiness • Experience contributing to process improvement, technology enablement, and modernization efforts, including scalable EDC build approaches, standard libraries, automation, AI-enabled data review workflows, and/or data visualization tools • People leadership experience, including coaching, developing, and managing CDM employees, contractors, or matrixed team members • Strong communication, collaboration, problem-solving, decision-making, and stakeholder management skills in a fast-paced, matrixed environment

🏖️ Benefits

• Annual bonus with a target of 30% of earned base salary • Eligibility to participate in equity-based long-term incentive program • Retirement savings plan with company match • Paid vacation, holiday, and personal days • Paid caregiver/parental and medical leave • Medical, prescription drug, dental, and vision coverage