Required skills
- Veeva Vault CTMS
- Veeva Vault Administration
- ServiceNow
- Jira Service Management
- Release Management
- Computer System Validation
- GxP
- 21 CFR Part 11
- GAMP 5
- URS
- FRS
- RTM
Languages: English
Job description
This is a remote, contract Veeva Vault CTMS Analyst role supporting live production systems for pharma, biotech, and life sciences sponsors, including big pharma clients. The core requirements are hands-on post-go-live CTMS support, functional and administrative configuration, incident and release management, CSV/GxP compliance, integration and data support,
Project overview
This is a remote, contract Veeva Vault CTMS Analyst role supporting live production systems for pharma, biotech, and life sciences sponsors, including big pharma clients. The core requirements are hands-on post-go-live CTMS support, functional and administrative configuration, incident and release management, CSV/GxP compliance, integration and data support, and strong requirements and stakeholder skills. Veeva Clinical suite exposure, Veeva certifications, Vault Loader or API experience, legacy CTMS migration, ITIL, and audit support are advantageous.
The requested experience is 4–5 years, while the description also states 3–5 years; this analysis uses the more specific 4–5-year structured input as the target band. The role is fully remote in India, requires immediate availability and UAN/Form 16, and works 1:00 PM–10:00 PM IST.
Responsibilities
- 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.
- 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.
- Review release notes for Veeva's three general releases each year and assess impact on client configuration and processes.
Requirements
- Veeva Vault CTMS functional knowledge of studies, sites, monitoring visits, milestones, issue and protocol deviation management, enrollment tracking, and trial oversight
- Veeva Vault administration of users, roles, security, workflows, lifecycles, document types, metadata, notifications, reports, and dashboards
- Production support including L1/L2/L3 incident, problem, and service request management against SLAs using ITSM tools such as ServiceNow or Jira Service Management
- Release management and testing including impact analysis, sandbox and regression testing, test scripts, defect management, and UAT coordination
- Computer system validation under GxP, 21 CFR Part 11, and GAMP 5, including change control, URS/FRS/RTM updates, periodic reviews, and Good Documentation Practice
- Integration and data support including interface and job monitoring, data reconciliation, and basic API troubleshooting
- Requirements analysis and documentation including user stories, acceptance criteria, functional specifications, process flows, and knowledge articles
- Client-facing stakeholder management, user training, and workshop facilitation
- Agile/Scrum ways of working, planning, organisation, and follow-through
- Hands-on post-go-live Veeva Vault CTMS support in an AMS or managed services setup, including big pharma client support
- 3–5 years of Business Analyst experience on Veeva Vault CTMS, with the target band stated elsewhere as 4–5 years
- Degree in life sciences, pharmacy, IT, or a related field
- Immediate availability for remote work in India, with UAN/Form 16
Project details
- Start: flexible
- Remote: remote
- Location: India, IN
- Languages: English
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