Veeva Vault Analyst / Veeva Systems Administrator (CTMS & eTMF)
Remote
Duration: 6-12 months
Job Summary
We are seeking an experienced Veeva Vault Analyst / Veeva Systems Administrator with strong expertise in Veeva Vault Clinical Suite, specifically CTMS (Clinical Trial Management System) and eTMF (Electronic Trial Master File). The ideal candidate will be responsible for administering, configuring, supporting, and optimizing Veeva Vault applications while collaborating with clinical operations, quality, and IT teams to ensure efficient clinical trial execution and regulatory compliance.
Required Skills
- 8+ years of experience as a Veeva Vault Analyst or Veeva Vault Systems Administrator.
- Hands-on experience with Veeva Vault CTMS and Veeva Vault eTMF (mandatory).
- Strong understanding of clinical trial processes, clinical operations, and TMF management.
- Experience configuring Veeva Vault, including workflows, lifecycles, security, permissions, object configuration, and document management.
- Knowledge of ICH-Google Cloud Platform, FDA, EMA, and other clinical regulatory requirements.
- Experience with user administration, role-based security, and system maintenance.
- Ability to troubleshoot system issues, perform root cause analysis, and coordinate with Veeva Support.
- Experience supporting system upgrades, releases, validation, and change management.
- Strong knowledge of clinical documentation, trial master files, and inspection readiness.
- Excellent communication and stakeholder management skills.
Responsibilities
- Administer and maintain Veeva Vault CTMS and eTMF environments.
- Configure Vault objects, workflows, lifecycles, security roles, and permissions.
- Support end users by troubleshooting issues, resolving tickets, and providing system guidance.
- Collaborate with Clinical Operations, Regulatory, Quality, and IT teams to enhance business processes.
- Manage user access, data integrity, and system compliance.
- Participate in system validation, testing, upgrades, and release management.
- Develop reports, dashboards, and system documentation.
- Ensure inspection readiness by maintaining compliant clinical documentation.
- Support integrations with other clinical systems when required.
- Provide user training and create SOPs, work instructions, and knowledge base documentation.
- Experience with additional Veeva Vault Clinical applications (Study Startup, Study Training, Payments, RTSM integrations, etc.).
- Knowledge of GxP, CSV (Computer System Validation), and 21 CFR Part 11 compliance.
- Experience with Agile or SDLC methodologies.
- Veeva Vault certifications are highly preferred.
- Bachelor's degree in Life Sciences, Computer Science, Information Systems, or a related field.
Keywords
Veeva Vault, Veeva CTMS, Veeva eTMF, Clinical Trial Management System, Electronic Trial Master File, Clinical Operations, TMF, ICH-Google Cloud Platform, GxP, 21 CFR Part 11, Vault Administration, Clinical Systems, Life Sciences, Pharmaceutical, Biotechnology, Clinical Research, System Administration, Clinical Documentation, Validation, Regulatory Compliance.
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