Associate Director, Clinical Data Management

Neurocrine Biosciences

. 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 .

Posted 10/16/2026full-timeRemote • California • United StatesSenior💰 $171,800 - $235,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Clinical Data Management, including leadership in data lifecycle processes, compliance with regulatory standards, and effective collaboration with cross-functional teams. Proficient in utilizing EDC platforms and metrics to ensure high-quality, inspection-ready clinical trial data deliverables.

Highest-signal resume keywords

Clinical Data Management LeadershipEDC/Database Build ExpertiseKnowledge of GCP and ICH GuidelinesExperience with CDASH and SDTM StandardsPeople Leadership and Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Data Lifecycle ManagementData Collection StrategyCRF DesignExternal Data IntegrationDatabase Lock ReadinessData Review and ReconciliationQuality ReviewsProcess ImprovementAutomation in Data ReviewData Visualization Tools

Soft Skills

Strong Communication SkillsCollaborationProblem-SolvingDecision-MakingStakeholder Management

Tools & Technologies

EDC PlatformsMedidata RaveCDM Metrics and DashboardsAI-Enabled Data Review WorkflowsStandard Libraries

Industry Keywords

BiopharmaceuticalCRO EnvironmentGood Clinical PracticeData Integrity PrinciplesInspection-Readiness Requirements

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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