Associate Director, Central Monitoring

🔥 11 minutes ago

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ImmunityBio, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

ImmunityBio, Inc. is a biotechnology company focused on developing innovative immunotherapies to enhance the immune system's ability to fight cancer and infectious diseases. By harnessing the power of the body’s immune response, ImmunityBio aims to provide breakthrough treatments that can improve patient outcomes and longevity in challenging diseases.

📋 Description

• Design, implement, and oversee the Central Monitoring Unit operational framework • Integrate CMU activities with existing Field Monitoring operations • Lead and chair the Clinical Data Quality and Governance Board • Drive cross-functional consensus on risk thresholds, QTLs, and KRIs • Own CMU SOPs, Work Instructions, and Risk Assessment and Categorization Tools • Integrate EDC, CTMS, RTSM, eCOA, and Safety DB data streams into a centralized surveillance engine • Escalate systemic issues identified by central monitors and coordinate targeted mitigation with Clinical Operations • Drive adoption of risk-based, Critical-to-Quality data review across Data Management and Biostatistics • Manage, coach, and evaluate Central Monitors • Perform ad-hoc and cross-functional projects as assigned

🎯 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 required • Experience in Clinical Operations, Data Management, or Biostatistics • Domestic and international clinical trials experience required • 3+ years of direct experience implementing or managing Risk-Based Quality Management frameworks required • Prior supervisory and department-building experience required • Deep expertise in ICH GCP E6(R3) and global regulatory expectations from FDA, EMA, and MHRA • Strong critical and logical thinking, including investigating unclear data signals • Excellent cross-functional leadership and ability to influence Medical Monitors, Biostatisticians, and Data Managers • Proficiency interpreting clinical data dashboards, visualizations, and KRI/QTL reports • Knowledge of Veeva Vault, including CDMS, CTMS, RBM, and QMS • Ability to maintain corporate confidentiality • Ability to work flexible hours for various time zones • Ability to travel up to 20% of the time • Ability to work in a standard office setting and use standard office equipment, including a computer

🏖️ Benefits

• Discretionary bonus • Equity award • 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 • Employee Discounts, Rewards and Perks • Paid Time Off (PTO) • 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 • Health and Wellness tools and resources • Remote work • Flexibility during standard business hours with manager approval