Associate Director, Central Monitoring
ImmunityBio, Inc.•El Segundo, CA
•$195,500 - $230,000•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
- 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.
Nice To Haves
- Master's degree preferred
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
