Associate Director – Field Monitoring Operations

🕒 il y a 3 jours

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ImmunityBio, Inc.

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501 - 1000 employés

🏥 Santé

💼 Conseil

🏭 Fabrication

Healthcare • Consulting • Manufacturing

ImmunityBio, Inc. est une entreprise de biotechnologie axée sur le développement d'immunothérapies innovantes pour renforcer la capacité du système immunitaire à combattre le cancer et les maladies infectieuses. En exploitant la puissance de la réponse immunitaire de l'organisme, ImmunityBio vise à fournir des traitements révolutionnaires qui peuvent améliorer les résultats et la longévité des patients atteints de maladies difficiles.

Description

• Lead the monitoring strategy, including Risk-Based Quality Management (RBQM) and Decentralized Clinical Trial (DCT) components, across the clinical trial portfolio • Safeguard data integrity, patient safety, and regulatory compliance • Lead remote Clinical Research Associates and Managers and mentor direct reports • Liaise with contract research organizations (CROs) and site investigators • Ensure trials follow protocols, SOPs, ICH GCPs, and applicable regulations • Design and oversee RBQM frameworks and modern data surveillance strategies aligned with ICH E6(R3) • Integrate remote, on-site, and decentralized monitoring with trial start-up, site activation, and study close-out • Optimize cross-functional study team operations, resource management, and study-team resourcing • Identify clinical operations process issues and lead best-practice and continuous-improvement initiatives • Provide quality oversight and contribute to inspection readiness • Own, review, revise, and delegate Clinical Operations SOP responsibilities • Contribute to strategic direction for multiple clinical studies • Provide training, mentoring, and review of study-specific documents • Share cross-team, site learnings, and best practices • Perform ad-hoc and cross-functional projects as assigned

🎯 Exigences

• Bachelor’s degree in life sciences, nursing, pharmacy, or a health-related field with 10+ years of progressive industry experience; or Master’s degree with 8+ years of progressive industry experience • 6+ years of management experience leading teams in clinical trial operations • Knowledge of clinical research, Good Clinical Practices (ICH E6(R3)), and regulatory requirements/guidelines • Expertise developing and managing Risk-Based Quality Management (RBQM) strategies • Proficiency interfacing with clinical research functions and driving cross-functional alignment • Excellent English verbal and written communication skills • Ability to maintain corporate confidentiality • Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook • Proficiency using Veeva Clinical Vault, CTMS, and eTMF • Ability to travel up to 75% based on study requirements • Ability to work flexible hours across various time zones • Ability to work in a standard office setting and use standard office equipment, including a computer

🏖️ Avantages

• Professional development opportunities • 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), including 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 • Flexible work schedule with manager approval