Senior Director, Global Clinical Data Management

🕒 il y a 2 mois

🇺🇸 États-Unis – Télétravail

💵 $230 000 - $280 000 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 3%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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ImmunityBio, Inc.

Site WebLinkedInTous les Emplois

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

• Provide strategic and operational leadership for all clinical trial data management activities across the global development portfolio • Ensure delivery of high-quality, regulatory-compliant clinical datasets to support submissions, publications, and decision-making • Define enterprise-wide clinical data governance strategy and ensure consistent, high-quality data across clinical development, real-world evidence, and digital health programs • Lead end-to-end data management operations including CRF design, database build, edit check strategy, and database lock • Responsible for the oversight of the Clinical Data Management team • Lead and mentor the leadership team in the development and improvement of skills, knowledge and abilities • Ensure effective quality, efficiency, and timeliness of data management projects through appropriate resource allocation and work prioritization • Establish global data standards, governance frameworks, and quality systems aligned with GCP, FDA, EMA, and ICH guidelines • Oversee clinical data vendors ensuring delivery on time, within budget, and to quality standards • Drive inspection readiness and regulatory audit support for clinical datasets • Collaborate within and across functional areas to evaluate, recommend, and implement process and technology improvement initiatives

🎯 Exigences

• Bachelor’s or Master’s degree in life sciences or technical discipline required • 12+ years of clinical data, clinical operations, or healthcare data systems experience required • Strong enterprise data governance experience required • Experience developing and managing a team direct and indirect reports required • Experience managing a global team strongly preferred • Deep knowledge of EDC systems, CDMS platforms, SDTM/CDISC standards • Working knowledge of the clinical research, Good Clinical Practices, and regulatory requirements/guidelines • Strong regulatory inspection experience (FDA/EMA) • Expertise in multi-study portfolio management • Ability to understand, and interpret clinical data analytics and analyze outcomes • Excellent project management skills with the ability to prioritize multiple tasks and objectives to consistently deliver to goals and timelines

🏖️ Avantages

• 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