ImmunityBio, Inc. · 2 days ago
Clinical Document Management Specialist
United States
Full-time
Remote
Entry Level
$33/hr - $36.30/hr
1+ years expImmunityBio, Inc. is a commercial-stage biotechnology company focused on developing cell and immunotherapy products to enhance the natural immune system. The Clinical Document Management Specialist role involves supporting clinical trials by managing essential study documents and ensuring compliance with regulatory guidelines.
Health CareHealth DiagnosticsTherapeutics
Responsibilities
Provides operational and administrative guidance for the study TMF/eTMF by assisting with the setup, organization, maintenance, and close-out of study specific TMF/eTMF
Maintains and updates of Company’s standard TMF Plan and TMF index, including indexing, tracking, and filing of paper and electronic clinical trial documents
Maintains the study TMF filing records system
Collaborates with the Clinical Study teams to guide proper submission and/or filing of clinical study related documents for completion of required tasks to meet departmental and project goals
Performs and oversees a review of documents filed in the TMF/eTMF as outlined by SOPs, company processes, procedures, and work instructions
Oversight in preparing, handling, distributing, filing and archiving of clinical documentation and reports per standard procedures
Collaborates in the review and improvement of SOPs and Departmental Policies and Procedures as it relates to TMF maintenance and archiving
Performs the regularly scheduled QC of the overall TMF/eTMF per the TMF Plan by monitoring completeness and quality of the TMF
Maintains internal audits and Regulatory Agency inspections by retrieving documents and providing reports
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 1+ years of clinical operations experience in pharma, biotech or CRO required; or
High School diploma with 4+ years of clinical operations experience in pharma, biotech or CRO required
Demonstrated knowledge of ICH and GCP guidelines
Proficiency in MS Word, Excel, PowerPoint, Outlook
Must be independent, flexible, and work well in a team environment, but also be self-directed and adapt to changing priorities and complete tasks under tight deadlines
Understand job-specific systems and processes as defined by Company SOPs and adhere to requirements listed in those documents. If any procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager
Solid communication skills and strong customer focus with the ability to interact in a cross functional organization
Maintain corporate confidentiality at all times Dependability and timeliness
Requires Critical Thinking skills, ability to lead co-workers, strong attention to detail, document organization skills, establishing priorities, scheduling, and meeting deadlines
Preferred
Trial Master File experience preferred
Demonstrated knowledge of clinical trial documents is preferred
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
Genetic Engineering News
2026-01-23
2026-01-22
Company data provided by crunchbase