Associate Director, Central Monitoring

🕒 Agosto 4

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ImmunityBio, Inc.

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

🏥 Saúde

💼 Consultoria

🏭 Manufatura

Healthcare • Consulting • Manufacturing

A ImmunityBio, Inc. é uma empresa de biotecnologia focada no desenvolvimento de imunoterapias inovadoras para aprimorar a capacidade do sistema imunológico de combater o câncer e doenças infecciosas. Ao aproveitar o poder da resposta imune do corpo, a ImmunityBio visa fornecer tratamentos revolucionários que possam melhorar os resultados e a longevidade dos pacientes em doenças desafiadoras.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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