Sobre este puesto de Veeva Clinical Analyst en ImmunityBio
Company Overview
ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.
Why ImmunityBio?
• ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
• Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
• Work with a collaborative team with the ability to work across different areas of the company.
• Ability to join a growing company with professional development opportunities.
Position Summary
Veeva Clinical Vault Systems Analyst provides foundational technical and operational support for ImmunityBio’s cloud-based Veeva Clinical Vault applications. Working under manager guidance, this role assists in basic system configuration, user access management, and routine troubleshooting. This is an excellent opportunity for someone with a baseline understanding of life sciences software to develop specialized skills in a highly regulated GxP environment.
Essential Functions
- Manage day-to-day user administration, including provisioning user accounts, assigning security profiles, and managing permission sets across Clinical Vault applications.
- Assist in executing low-to-medium complexity system configurations, such as modifying picklists, updating document types, and adjusting basic lifecycle states or workflows.
- Create basic reports and Dashboards based upon user provided requirements.
- Monitor the access email inbox, acting as the first line of triage for end-user support. Diagnose access issues, clarify system behavior for users, and escalate complex technical bugs to senior team members or Veeva support.
- Assist in drafting documentation for Computer Software Validation (CSV). Participate in executing User Acceptance Testing (UAT) scripts and documenting results in strict accordance with GxP and 21 CFR Part 11 regulations.
- Support the review process for Veeva’s routine software updates. Assist in testing new platform features in sandbox environments before they are pushed to production.
- Maintain data integrity within the Vault by running routine reports, identifying data entry inconsistencies, and assisting with bulk data uploads or clean-up tasks.
- Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
- Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.
Education & Experience
- Bachelor’s degree in Information Technology, Computer Science, Bio-Informatics, Life Sciences, or a related field is required.
- 2+ years of experience in an IT support, data coordination, or application management role is required.
- Prior exposure to software systems used in clinical trials, pharmaceutical manufacturing, or regulatory affairs is highly preferred.
Knowledge, Skills, & Abilities
- Foundational knowledge or academic exposure to cloud systems. Direct experience using or configuring Veeva Vault applications (such as eTMF, CTMS, CDMS/EDC or RIM) is a major plus but not strictly mandatory if the candidate has strong technical aptitude.
- Understanding GxP validation meaning and a willingness to learn the rigorous documentation standards required in the life sciences industry.
- Familiarity with Excel (for data mapping). Hands-on working knowledge of basic configurations, Veeva security, document types and reports in any of the Veeva vaults.
- Understanding of DIA Reference model, Submissions structures, EDC development principles, Software Development Life Cycle.
- Good communication skills and ability to collaborate with all levels of an organization.
- Ability to adapt quickly, work independently and manage competing priorities.
- Strong attention to detail.
- Strong research & analysis skills, creative thinker who can focus on the details without losing sight of the big picture.
Working Environment / Physical Environment
- This position works on site based in Dunkirk, NY.
- Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.
- Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
- Lift and carry materials weighing up to 20 pounds
This position is eligible for a discretionary bonus and equity award. The hourly base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.
$42.20 (entry-level qualifications) to $47.12 (highly experienced) per hour
The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
ImmunityBio uses artificial intelligence (AI) tools to assist with sourcing and identifying potential candidates for open positions. These tools help us reach qualified applicants and improve the efficiency of our recruitment outreach. No preference is given to applicants sourced or identified by AI tools.
Important: AI is not used to screen, evaluate, rank, assess, or make hiring decisions about applicants. All applications are reviewed by human recruiters and hiring managers. Hiring decisions are made solely by ImmunityBio personnel without automated decision-making.
We are committed to equal employment opportunity and ensure that all candidates are assessed based on their qualifications, skills, and experience through human review.
ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: 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.
At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.