Veeva Vault eTMF/CTMS Support/Admin

Veeva Vault Clinical Administration & Configuration

• Provide production support and system administration for Veeva Vault Clinical, including eTMF and CTMS.
• Configure and maintain users, groups, application roles, document types, document properties, lifecycles, workflows, picklists, and layout rules.
• Process new user access requests and configure or modify existing user accounts based on approved requests.
• Perform periodic user access reviews and support license optimization activities.
• Validate monthly HR active-user reports and deactivate terminated or inactive users as required.
• Support training, sandbox, validation, and production environments, including environment refresh activities.

Veeva Vault Data Migration

• Support end-to-end data and document migration from legacy systems, CRO repositories, external sources, and other Vault environments into Veeva Vault Clinical.
• Participate in migration planning, source data assessment, data mapping, transformation, loading, validation, reconciliation, and post-migration support.
• Develop and maintain source-to-target mapping specifications for documents, metadata, objects, and related records.
• Perform data cleansing, normalization, transformation, and preparation for Vault loading.
• Prepare and validate migration load files based on Vault configurations and business rules.
• Support bulk document, metadata, and object loading using Vault Loader and Veeva Vault APIs, as appropriate.
• Create API queries and data extracts to support migration, reconciliation, automation, and validation requirements.
• Perform pre-load and post-load validation to verify data completeness, accuracy, metadata consistency, and successful migration.
• Conduct source-to-target reconciliation and identify missing, duplicate, rejected, or incorrectly transformed records.
• Troubleshoot migration errors and failed records, perform root-cause analysis, correct issues, and support reprocessing.
• Participate in mock migrations, migration dry runs, cutover planning, production migration, reconciliation, and post-go-live stabilization.
• Maintain migration documentation including mapping specifications, load files, execution evidence, error logs, reconciliation reports, and validation documentation.
• Ensure data migration activities comply with applicable GxP, data integrity, validation, and change-control requirements.

Production Support & Incident Management

• Provide day-to-day production support for Veeva Vault Clinical applications.
• Troubleshoot application, configuration, access, workflow, document, and data-related issues.
• Perform Root Cause Analysis (RCA) and recommend Corrective and Preventive Actions (CAPA).
• Resolve technical issues within established service levels and escalate to appropriate teams or vendors when necessary.
• Create and manage ServiceNow incidents and service requests for incoming support requests.
• Communicate ticket numbers, progress, resolutions, and required follow-up actions to users.
• Coordinate with CROs and external users as part of service delivery.

API & Automation Support

• Create and maintain Veeva Vault API queries to support automation, integration, reporting, and migration requirements.
• Collaborate with automation and integration teams on Vault-related technical solutions.
• Support troubleshooting of API, integration, data-load, and automation issues.
• Provide data extracts and queries for reconciliation, migration, and operational requirements.

Validation & Change Management

• Work closely with validation teams to implement standard changes and Requests for Change (RFCs).
• Support testing and validation of configuration changes and data migrations.
• Participate in test planning, test execution, defect resolution, and implementation verification.
• Ensure changes to production systems follow established change-control and computerized system validation procedures.
• Maintain appropriate documentation and traceability for GxP system changes.

GxP Compliance & Audit Support

• Support GxP-regulated Veeva Vault Clinical applications within the pharmaceutical/life sciences environment.
• Apply controlled document management and data-integrity principles.
• Participate in internal and external audits of IT systems and associated business processes.
• Provide configuration documentation, user access records, validation evidence, migration documentation, and other information required during audits.
• Ensure administration, production support, and data migration activities follow established SOPs, quality standards, and validation procedures.

Required Skills & Experience

• Hands-on experience with Veeva Vault Clinical administration and production support.
• Experience with Veeva eTMF and/or CTMS.
• Strong knowledge of:
  • Users and groups
  • Application roles
  • Document types and properties
  • Lifecycles and workflows
  • Picklists
  • Layout rules
• Experience performing Veeva Vault data and document migration.
• Experience with:
  • Source-to-target mapping
  • Data cleansing and transformation
  • Metadata and document loading
  • Bulk data loading
  • Migration validation
  • Data reconciliation
  • Migration error analysis and reprocessing
• Working knowledge of Veeva Vault APIs and Vault Loader.
• Experience supporting GxP-regulated computerized systems.
• Understanding of controlled document management and data integrity principles.
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