Associate Director, Central Monitoring
ImmunityBio•El Segundo, CA
•Remote
About The Position
The Associate Director, Central Monitoring Unit (CMU) Lead will serve as the primary architect and operational leader of the company's Risk-Based Quality Management (RBQM) strategy. This role acts as the execution arm for central data surveillance and will transition the organization from traditional 100% data review to a proactive, critical-thinking model. This role will chair the Clinical Data Quality and Governance Board (CDQGB) and ensure all central monitoring activities align with global regulatory expectations (ICH E6(R3)).
Requirements
- Bachelor's degree in a clinical research, science, or health-related field required (Master's degree preferred)
- 8+ years of progressive experience in clinical research (Clinical Operations, Data Management, or Biostatistics), with domestic and international clinical trials experience required.
- 3+ years of direct experience implementing or managing Risk-Based Quality Management (RBQM) frameworks required
- Prior supervisory and department-building experience required.
- Deep expertise in ICH GCP E6(R3) and global regulatory expectations (FDA, EMA, MHRA) regarding risk-based monitoring.
- Strong critical and logical thinking with the ability to "investigate" data signals that don't have a clear answer on day one.
- Excellent cross-functional leadership skills; ability to influence Medical Monitors, Biostatisticians, and Data Managers.
- Proficient in interpreting clinical data dashboards, visualizations, and KRI/QTL reports.
- Knowledge of modern clinical systems, specifically Veeva Vault (CDMS, CTMS, RBM, QMS).
- Ability to maintain corporate confidentiality at all times.
Responsibilities
- Design, implement, and oversee the CMU operational framework, ensuring seamless integration with existing Field Monitoring operations.
- Lead and chair the Clinical Data Quality and Governance Board (CDQGB), driving cross-functional consensus on risk thresholds (QTLs/KRIs).
- Act as the primary process owner for all CMU-related SOPs, Work Instructions, and Risk Assessment and Categorization Tools (RACT).
- Manage the integration of multi-vendor data streams (EDC, CTMS, RTSM, eCOA, Safety DB) into a centralized surveillance engine (e.g., Veeva RBM).
- Act as the ultimate escalation point for systemic issues identified by central monitors, partnering with Clinical Operations to execute targeted mitigation.
- Drive the cultural shift across Data Management and Biostatistics to adopt risk-based, Critical-to-Quality (CtQ) focus over administrative data review.
- Manage, coach, and evaluate a team of Central Monitors.
- Perform ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities.
Benefits
- Medical, Dental and Vision Plan Options
- Health and Financial Wellness Programs
- Employer Assistance Program (EAP)
- Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
- Healthcare and Dependent Care Flexible Spending Accounts
- 401(k) Retirement Plan with Company Match
- 529 Education Savings Program
- Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
- Paid Time Off (PTO) includes: 11 Holidays
- Exempt Employees are eligible for Unlimited PTO
- Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
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What This Job Offers
Job Type
Full-time
Career Level
Manager
