Looking for immediate joiners only. If interested, please revert back with your resume , CTC , ECTC and Veeva Valut Certification ( optional ) : [email protected]

Role overview

Volga Infotech is hiring a Analyst to support Veeva Vault CTMS in production for our pharma, biotech and life sciences clients. You will be the functional owner of the system after go-live across six areas: production support, Veeva administration, release management, enhancements and change requests, integration and data support, and adoption, compliance and continuous improvement.

You will work directly with client Clinical Operations teams, Veeva, and our delivery team to keep the system stable, validated under GxP and 21 CFR Part 11, and improving with each release. This is a fully remote role, and we need someone who can join immediately and pick up live client support from day one.

Experience : 4–5 years as an Analyst on Veeva Vault CTMS, including post-go-live support

Engagement type Application maintenance and support (AMS) / managed services

Key responsibilities

1.>Production support

- Manage L1/L2/L3 incidents and service requests for Veeva Vault CTMS within agreed SLAs.
- Troubleshoot user issues across studies, sites, monitoring visits, milestones and issue management.
- Investigate and resolve workflow failures, stuck tasks and access or permission issues.
- Perform root-cause analysis on repeat incidents and drive permanent fixes.
- Escalate product defects to Veeva Support and manage vendor escalations through to closure.
- Report ticket volumes, SLA performance and top issues to client stakeholders.

1. Veeva administration

• Manage users, roles, security profiles, permission sets and sharing settings in line with access SOPs.
- Maintain security configuration and support periodic user access reviews.
- Configure and maintain workflows, object and document lifecycles, document types and metadata.
- Set up and maintain notifications, picklists, page layouts and other routine configuration.
- Maintain CTMS master data such as studies, study countries, sites, milestone templates and monitoring visit templates.

2>Release management

- Review release notes for Veeva's three general releases each year and assess impact on client configuration and processes.




- Complete impact analysis and decide which new features to enable, defer or leave off.
- Test new and changed functionality in the sandbox before production.
- Run and maintain the regression test suite for core CTMS processes.
- Update validation documents and confirm production readiness with client QA and business owners.
- Communicate release changes to users before each go-live.

1. Enhancements and change requests

• Gather and analyse requirements for new workflows, fields, objects, reports and dashboards.
- Write user stories, acceptance criteria, functional specifications and process flows.
- Assess, estimate and prioritise change requests with client Clinical Operations.
- Configure or coordinate configuration changes, then test and deploy them through change control.
- Keep the enhancement backlog aligned with evolving business requirements.

3>Integration and data support

- Monitor integrations between CTMS and connected systems such as eTMF, EDC, IRT and data warehouses.
- Investigate failed interfaces and jobs, identify root causes and coordinate fixes.
- Troubleshoot API and integration issues with technical and vendor teams.
- Resolve data issues, run data reconciliation and perform data corrections through approved processes.
- Keep master data aligned across CTMS and connected systems.

4>Adoption, compliance and continuous improvement

- Deliver user training, onboarding and refresher sessions for CRAs, study managers and other CTMS users.
- Update SOPs, work instructions and process documentation as the system changes.
- Write and maintain knowledge articles and FAQs for users and the support team.
- Keep the system in a validated state under GxP, 21 CFR Part 11 and GAMP 5 through change control, periodic reviews and audit-trail reviews.
- Support client QA during audits and regulatory inspections.
- Monitor system adoption and usage, and recommend process and configuration improvements.





Required qualifications

- Degree in life sciences, pharmacy, IT or a related field.
- 3–5 years of experience as a Business Analyst on Veeva Vault CTMS.
- Hands-on experience supporting Veeva Vault CTMS in production after go-live, in an AMS or managed services setup.
- Prior experience supporting a big pharma client.
- Good understanding of clinical trial operations and ICH-GCP (E6).
- Available to join immediately and work remotely.

Must-have skills

- Veeva Vault CTMS functional knowledge: studies, study countries, sites, monitoring visits and trip reports, milestones, issue and protocol deviation management, enrollment tracking and trial oversight.
- Veeva Vault administration: users, roles, security profiles, permission sets, workflows, lifecycles, document types, metadata, notifications, reports and dashboards.
- Production support: L1/L2/L3 incident, problem and request management against SLAs, using ITSM tools such as ServiceNow or Jira Service Management.
- Release management and testing: release impact analysis, sandbox and regression testing, test script writing and execution, defect management and UAT coordination.
- Validation (CSV): change control, URS/FRS/RTM updates and periodic review under GxP, 21 CFR Part 11 and GAMP 5, with sound Valuable Documentation Practice.
- Integration and data: monitoring interfaces and jobs, data reconciliation and basic API troubleshooting.
- Requirements and documentation: user stories, acceptance criteria, functional specifications, process flows and knowledge articles.
- Stakeholder management: confident client-facing communication, training delivery and workshop facilitation.
- Ways of working: experience in Agile/Scrum teams; strong planning, organisation and follow-through on commitments.

Good to have

- Veeva Vault certification (CTMS, Clinical Operations or Vault Administrator).
- Exposure to the wider Veeva Clinical suite (eTMF, Study Start-Up, Site Connect, Site Payments).
- Experience with Vault Loader, data loads or Vault API.
- Experience migrating from a legacy CTMS such as Siebel.
- ITIL Foundation or a similar service management certification.
- Experience supporting regulatory inspections or client audits of a CTMS.

📌 Veeva Vault CTMS Analyst (India)
🏢 Volga Infotech
📍 India