Veeva Clinical Analyst

nant; City of Dunkirk (NY); On-site; USD 70,000 - 100,000; Full time

Job summary

ImmunityBio is seeking a Veeva Clinical Vault Systems Analyst to provide foundational technical and operational support for its cloud-based Clinical Vault applications. Under guidance, you will assist in basic configuration, user access management, and routine troubleshooting in a highly regulated GxP environment.

Responsibilities include day-to-day user administration, configuring simple workflows, creating basic reports and dashboards, monitoring access issues, drafting CSV validation

Qualifications

• Bachelor's degree in IT, CS, bio-informatics or a related field.
• 2+ years IT support, data coordination or application management experience.
• Prior exposure to software systems used in clinical trials, pharmaceutical manufacturing, or regulatory affairs preferred.

Responsibilities

• Manage day-to-day user administration across Clinical Vault applications.
• Assist in configuring low-to-medium complexity system configurations and workflows.
• Create basic reports and dashboards based on user requirements.
• Monitor the access email inbox and triage end-user issues.
• Assist in drafting documentation for CSV validation and participate in UAT.
• Support testing of platform features in sandbox environments before production.
• Maintain data integrity and assist with data uploads or cleanup tasks.
• Create, edit and adhere to SOPs and standard templates.
• Perform ad-hoc and cross-functional duties as assigned.

Job description

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 escal...
• 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 det