Veeva Clinical Analyst

ImmunityBio, Inc.•Dunkirk, NY

1d•$42 - $47•Onsite

About The Position

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.

Requirements

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.
Foundational knowledge or academic exposure to cloud systems.
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).
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.

Nice To Haves

Prior exposure to software systems used in clinical trials, pharmaceutical manufacturing, or regulatory affairs is highly preferred.
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.
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.

Responsibilities

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.

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