Head of Clinical Data Management
Neurocrine Biosciences
June 27, 2026
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
About The Role
Strategic and operational leadership for Clinical Data Management (CDM) across multiple clinical programs to deliver high-quality, inspection-ready clinical data for development, regulatory submissions, and business decisions.
Responsibilities
- Lead CDM strategy/operating model, budget/resource planning, vendor ecosystem, and leadership capability development.
- Ensure execution across the clinical data lifecycle: data collection strategy, EDC/database build, external data integration, review/reconciliation, database lock readiness, and vendor oversight.
- Develop CDM plans and deliverables (data management plans, data review plans, specs, edit checks, query management, quality reviews/audits, database lock plans).
- Provide early input into protocol/CRF design, data standards, endpoint implementation, and cross-study consistency.
- Partner with Biostatistics/Stat Programming for traceability from protocol/CRFs to SDTM-ready and analysis-ready datasets.
- Establish/monitor CDM metrics, dashboards, and governance; drive risk-based quality and predictability.
- Resolve complex CDM issues; oversee CROs/vendors/contractors and represent CDM in governance meetings.
- Ensure compliance with GCP/ICH, data integrity, SOPs, and support inspections/audits as needed.
- Lead/coach CDM staff and contribute to resource planning, succession planning, and modernization (scalable EDC, standard libraries, automation/AI-enabled review).
Requirements
- BS/BA + 12+ yrs OR MS + 10+ yrs OR PhD + 8+ yrs CDM leadership in biotech/pharma/CRO.
- Strong clinical data lifecycle knowledge; EDC/CDM systems (Medidata Rave preferred); CDASH/SDTM/controlled terminology and standard CRF libraries.
- Experience partnering with Biostatistics/Stat Programming; overseeing outsourced/hybrid models.
- Knowledge of GCP/ICH/regulatory expectations, inspection readiness, data integrity, and CDM metrics.
- Strong people leadership and stakeholder management.
Benefits / Pay (as stated)
- Base salary: $192,500–$263,000; annual bonus target 35%; equity long-term incentive eligibility.
- Retirement match, paid vacation/holidays/personal days, caregiver/parental and medical leave, and medical/dental/vision.
Application
- Apply even if your experience/qualifications don’t fully match the requirements.
Strategic and operational leadership for Clinical Data Management (CDM) across multiple clinical programs to deliver high-quality, inspection-ready clinical data for development, regulatory submissions, and business decisions.
Responsibilities
- Lead CDM strategy/operating model, budget/resource planning, vendor ecosystem, and leadership capability development.
- Ensure execution across the clinical data lifecycle: data collection strategy, EDC/database build, external data integration, review/reconciliation, database lock readiness, and vendor oversight.
- Develop CDM plans and deliverables (data management plans, data review plans, specs, edit checks, query management, quality reviews/audits, database lock plans).
- Provide early input into protocol/CRF design, data standards, endpoint implementation, and cross-study consistency.
- Partner with Biostatistics/Stat Programming for traceability from protocol/CRFs to SDTM-ready and analysis-ready datasets.
- Establish/monitor CDM metrics, dashboards, and governance; drive risk-based quality and predictability.
- Resolve complex CDM issues; oversee CROs/vendors/contractors and represent CDM in governance meetings.
- Ensure compliance with GCP/ICH, data integrity, SOPs, and support inspections/audits as needed.
- Lead/coach CDM staff and contribute to resource planning, succession planning, and modernization (scalable EDC, standard libraries, automation/AI-enabled review).
Requirements
- BS/BA + 12+ yrs OR MS + 10+ yrs OR PhD + 8+ yrs CDM leadership in biotech/pharma/CRO.
- Strong clinical data lifecycle knowledge; EDC/CDM systems (Medidata Rave preferred); CDASH/SDTM/controlled terminology and standard CRF libraries.
- Experience partnering with Biostatistics/Stat Programming; overseeing outsourced/hybrid models.
- Knowledge of GCP/ICH/regulatory expectations, inspection readiness, data integrity, and CDM metrics.
- Strong people leadership and stakeholder management.
Benefits / Pay (as stated)
- Base salary: $192,500–$263,000; annual bonus target 35%; equity long-term incentive eligibility.
- Retirement match, paid vacation/holidays/personal days, caregiver/parental and medical leave, and medical/dental/vision.
Application
- Apply even if your experience/qualifications don’t fully match the requirements.