Job Title: Veeva Vault CTMS Analyst

Experience: 4–5 Years

Job Location: Remote

Job Type: Contract (3–6 Months)

Work Timings: 1:00 PM – 10:00 PM IST

Joining: Immediate Joiners Preferred

Job Overview

We are looking for an experienced Veeva Vault CTMS Analyst with 4–5 years of hands-on experience in Veeva Vault Clinical Trial Management System (CTMS), particularly in post-implementation production support and application maintenance services (AMS).

The candidate will be responsible for providing functional and administrative support for Veeva Vault CTMS, managing production incidents, system configurations, release management, enhancements, integrations, and compliance activities.

The ideal candidate should have strong knowledge of clinical trial operations, pharmaceutical processes, GxP compliance, and 21 CFR Part 11 requirements. Experience working with large pharmaceutical or life sciences clients is highly preferred.

Key Responsibilities

- Veeva Vault CTMS – Production Support

- Provide L1/L2/L3 production support for Veeva Vault CTMS and resolve incidents within defined SLAs.
- Troubleshoot issues related to clinical studies, study sites, monitoring visits, milestones, workflows, and user access.
- Investigate workflow failures, stuck tasks, permission issues, and system-related errors.
- Perform root cause analysis (RCA) and implement permanent solutions for recurring issues.
- Coordinate with Veeva Support and technical teams for product defects and escalations.
- Manage incidents, service requests, and problem tickets using ServiceNow or Jira Service Management.

2. Veeva Vault Administration & Configuration
- Manage user accounts, roles, security profiles, permission sets, and access controls.
- Configure and maintain workflows, object lifecycles, document types, metadata, notifications, and page layouts.
- Maintain CTMS master data, including studies, study countries, sites, milestones, and monitoring visit templates.
- Support periodic user access reviews and ensure compliance with access management policies.
- Generate and maintain reports and dashboards to support clinical operations.

3. Release Management & Testing




- Review Veeva Vault release notes and assess the impact of new features and enhancements.
- Perform release impact analysis and coordinate feature enablement.
- Conduct sandbox testing, regression testing, and functional validation before production releases.
- Prepare and execute test scripts and coordinate User Acceptance Testing (UAT).
- Track defects and ensure their resolution before deployment.
- Update validation documentation and coordinate production readiness with QA and business stakeholders.

4. Enhancements & Change Requests
- Gather business requirements from Clinical Operations teams.
- Prepare functional specifications, user stories, acceptance criteria, and process flow documents.
- Identify opportunities for system enhancements and process improvements.
- Coordinate configuration changes and ensure proper testing and deployment through change control.
- Maintain enhancement backlogs and prioritise change requests based on business requirements.

5. Integration & Data Management
- Monitor integrations between CTMS and other clinical systems, including eTMF, EDC, IRT, and data warehouses.
- Troubleshoot failed interfaces, integration jobs, and data synchronization issues.
- Coordinate with technical teams to resolve API and integration-related issues.
- Perform data reconciliation, data validation, and approved data corrections.
- Ensure consistency and accuracy of clinical trial master data across connected applications.

6. Compliance, Documentation & User Training
- Ensure the system remains compliant with GxP, 21 CFR Part 11, GAMP 5, and Good Documentation Practices (GDP).
- Support Computer System Validation (CSV), change control, periodic reviews, and audit-trail reviews.
- Maintain validation documents, including URS, FRS, RTM, and test evidence.




- Support client audits and regulatory inspections.
- Conduct user onboarding, training, and refresher sessions for CRAs, study managers, and clinical operations teams.
- Maintain SOPs, work instructions, FAQs, and knowledge base articles.

Mandatory Skills & Qualifications

- 4–5 years of overall experience, with approximately 3–5 years of relevant Veeva Vault CTMS experience.
- Hands-on experience in Veeva Vault CTMS production support after go-live.
- Strong functional knowledge of Veeva Vault CTMS and clinical trial management processes.
- Experience in application maintenance and support (AMS) or managed services environments.
- Experience supporting pharmaceutical, biotechnology, or life sciences clients, preferably large pharma clients.
- Good understanding of clinical trial processes and ICH-GCP (E6).
- Hands-on knowledge of Veeva Vault administration, including users, roles, permissions, workflows, and lifecycles.
- Experience in incident management, problem management, SLA tracking, and root cause analysis.
- Knowledge of release management, regression testing, UAT, and defect management.
- Understanding of CSV, GxP, 21 CFR Part 11, GAMP 5, and change control.
- Exposure to integrations, APIs, data reconciliation, and connected clinical applications.
- Solid documentation, analytical, communication, and stakeholder management skills.
- Ability to work independently and handle client-facing responsibilities.

Good-to-Have Skills

- Veeva Vault CTMS, Clinical Operations, or Vault Administrator certification.
- Exposure to other Veeva Clinical applications such as eTMF, Study Start-Up, Site Connect, and Site Payments.
- Experience with Vault Loader, Vault API, and data migration activities.
- Knowledge of legacy CTMS platforms such as Oracle Siebel CTMS.
- ITIL Foundation or other IT Service Management certifications.
- Experience supporting regulatory audits and inspections.
- Experience working in Agile/Scrum environments.

Education

- Bachelor's degree in Life Sciences, Pharmacy, Information Technology, Computer Science, or a related discipline.

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📌 Veeva Vault CTMS Analyst (India)
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