ImmunityBio, Inc. · 7 hours ago
Trial Master File Analyst
California, United States
Full-time
Hybrid
Mid Level
$37/hr - $40.70/hr
3+ years expImmunityBio, Inc. is a commercial-stage biotechnology company focused on developing innovative cell and immunotherapy products. The Trial Master File Analyst will maintain the TMF, coordinate with Clinical Operations, and ensure compliance with quality control processes throughout clinical trials.
Health CareHealth DiagnosticsTherapeutics
Responsibilities
Generate, organize, deliver TMF performance metrics for various functional areas
Support Trial Operations with the TMF implementation and throughout the study as needed with oversight by the designated Clinical Programs Manager(s) and Clinical Trial Managers CTM(s)
Perform risk-based periodic reviews of quality issue responses and document quality reviews, as needed, on site, country, or study level or as delegated by Trial Maintenance Management
Perform document review for suitability, content, legibility, and conformance with good documentation practices (GDP)
Respond to or delegate TMF alerts, tasks, and quality issues as TMF Subject Matter Expert (SME)
Raise quality issues for TMF issues found, as applicable
Ensure similar documentation issues are handled uniformly across all trials/programs
Exhibit knowledge of applicable FDA, ICH/GCP guidelines to perform review on documents that have been filed to the TMF and to support inspection readiness goals
Participate in project specific meetings and educate functional leads in TMF requirements
Ensure accurate completion and maintenance of TMF
Demonstrate ability to make sound business decisions based on evidence (SOPs and guidance documents) and experience, deliver on commitments, share knowledge, acknowledge other achievements, and collaborate with peers in order to meet objectives or timelines in a rapidly changing environment
Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities
Qualification
Required
Bachelor's degree with 3+ years of relevant Trial Master File experience; or
High School diploma with 6+ years relevant clinical research experience
Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; previous interaction with operational project teams
Ability to adapt to a changing environment and handle multiple priorities
Detail and process oriented
Superb organizational and time management skills
Flexible and adaptable to a developing work environment; willingness to learn
Positive attitude and approach
Excellent communication skills, oral and written
Self-motivation with the ability to work under pressure to meet deadlines
Works well independently as well as in a team environment
Interact with internal and external sites and vendors with high degree of professionalism and discretion
Multi-tasking capability
Computer proficiency (MS Office - Word, Excel, Power Point), aptitude for training, capable of operating standard office equipment and learning new systems
Preferred
Experience in study start-up, study maintenance and document quality reviews
Relevant experience in clinical trials related roles (i.e. clinical operations and project management)
Previous experience with independently managing projects and handling concurrent tasks in a fast-paced environment and delivering results within tight timelines
Experience with eTMF maintenance
Veeva Vault experience
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
We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
Company
ImmunityBio, Inc.
ImmunityBio, Inc.
501-1000 employees
H1B Sponsorship
ImmunityBio, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (4)
2023 (6)
2022 (7)
2021 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.36BKey Investors
Oberland CapitalNantCapitalPatrick Soon-Shiong
2025-07-25Post Ipo Equity· $80M
2025-04-08Post Ipo Equity· $75M
2024-12-11Post Ipo Equity· $100M
Leadership Team
Enrique Diloné
Chief Technology Officer
Leonard Sender
COO
Recent News
Clinical Trials Arena
2026-01-16
Company data provided by crunchbase