Associate Director, Central Monitoring
ImmunityBio, Inc.
August 25, 2026
Remote
United States
Clinical Research and Development
Position Summary
- Associate Director, Central Monitoring Unit (CMU) Lead: Architect and lead the company’s Risk-Based Quality Management (RBQM) strategy; chair the Clinical Data Quality and Governance Board (CDQGB) and ensure central monitoring aligns with ICH E6(R3).
Responsibilities
- Design, implement, and oversee the CMU operational framework and integrate with Field Monitoring.
- Chair CDQGB; drive cross-functional consensus on risk thresholds (QTLs/KRIs).
- Own CMU-related SOPs, Work Instructions, and Risk Assessment and Categorization Tools (RACT).
- Integrate multi-vendor data streams (EDC, CTMS, RTSM, eCOA, Safety DB) into a centralized surveillance engine (e.g., Veeva RBM).
- Escalate systemic issues from central monitors; partner with Clinical Operations on mitigation.
- Lead the shift toward risk-based Critical-to-Quality (CtQ) focus.
- Manage, coach, and evaluate Central Monitors.
- Perform ad-hoc/cross-functional projects as assigned.
Qualifications
- Bachelor’s degree in clinical research/science/health field required (Master’s preferred).
- 8+ years progressive clinical research experience (Clinical Ops, Data Mgmt, or Biostatistics), including domestic/international trials.
- 3+ years direct RBQM framework implementation/management.
- Prior supervisory and department-building experience required.
Skills/Abilities
- Deep ICH GCP E6(R3) and global risk-based monitoring knowledge (FDA/EMA/MHRA).
- Strong critical/logical thinking; ability to investigate unclear data signals.
- Cross-functional leadership; influence Medical Monitors, Biostatisticians, Data Managers.
- Proficient with clinical dashboards and KRI/QTL reporting; knowledge of Veeva Vault (CDMS/CTMS/RBM/QMS).
Benefits/Compensation (as stated)
- Discretionary bonus and equity award; base pay range listed.
Application Instructions
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).
- Associate Director, Central Monitoring Unit (CMU) Lead: Architect and lead the company’s Risk-Based Quality Management (RBQM) strategy; chair the Clinical Data Quality and Governance Board (CDQGB) and ensure central monitoring aligns with ICH E6(R3).
Responsibilities
- Design, implement, and oversee the CMU operational framework and integrate with Field Monitoring.
- Chair CDQGB; drive cross-functional consensus on risk thresholds (QTLs/KRIs).
- Own CMU-related SOPs, Work Instructions, and Risk Assessment and Categorization Tools (RACT).
- Integrate multi-vendor data streams (EDC, CTMS, RTSM, eCOA, Safety DB) into a centralized surveillance engine (e.g., Veeva RBM).
- Escalate systemic issues from central monitors; partner with Clinical Operations on mitigation.
- Lead the shift toward risk-based Critical-to-Quality (CtQ) focus.
- Manage, coach, and evaluate Central Monitors.
- Perform ad-hoc/cross-functional projects as assigned.
Qualifications
- Bachelor’s degree in clinical research/science/health field required (Master’s preferred).
- 8+ years progressive clinical research experience (Clinical Ops, Data Mgmt, or Biostatistics), including domestic/international trials.
- 3+ years direct RBQM framework implementation/management.
- Prior supervisory and department-building experience required.
Skills/Abilities
- Deep ICH GCP E6(R3) and global risk-based monitoring knowledge (FDA/EMA/MHRA).
- Strong critical/logical thinking; ability to investigate unclear data signals.
- Cross-functional leadership; influence Medical Monitors, Biostatisticians, Data Managers.
- Proficient with clinical dashboards and KRI/QTL reporting; knowledge of Veeva Vault (CDMS/CTMS/RBM/QMS).
Benefits/Compensation (as stated)
- Discretionary bonus and equity award; base pay range listed.
Application Instructions
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).