Veeva vault Consultant

Hi All

Client:TCS

Location:MarlboroughMA

We are seeking a seasoned Technical Lead to own the end-to-end technical delivery operations and continuous improvement of the Veeva Vault Platform with primary focus on RIM (Regulatory Information Management) and eTMF (Electronic Trial Master File). This role partners closely with business stakeholders to understand needs proactively prevent issues and ensure the platform is compliant performant and user-friendly across global teams.

• Stakeholder Engagement & Requirement Analysis

  • Work closely with Regulatory Affairs Clinical Operations Quality and IT to gather requirements clarify pain points and translate business needs into technical solutions and configurations.
  • Facilitate workshops demos and UAT ensuring clear communication and adoption.

• Platform Ownership & Delivery

  • Lead the design configuration and rollout of features and enhancements in Veeva Vault RIM and eTMF (metadata lifecycles workflows roles permissions).
  • Drive release planning change management sandbox testing and controlled production deployments following SDLC and validation standards.

• Operations Support & Proactive Monitoring

  • Maintain and support the platform ensuring high availability performance and data integrity.
  • Implement proactive monitoring incident triage root cause analysis and preventive fixes; manage L2/L3 tickets and vendor escalations.
  • Establish and refine SOPs runbooks and knowledge base articles.

• Compliance & Governance

  • Ensure configurations and processes align with GxP 21 CFR Part 11 Annex 11 and organizational validation standards.
  • Partner with QA/Compliance to maintain audit readiness validation documentation (URS/FS/DS IQ/OQ/PQ) and change control records.

• Integration & Data Management

  • Oversee integrations between Veeva Vault and adjacent systems (e.g. CTMS ERP Identity/SSO DMS).
  • Govern data migration archival retention and reconciliations; ensure traceability and consistent taxonomy/metadata.

• Team Leadership & Collaboration

  • Mentor administrators/configurators; enforce best practices coding standards (where applicable) and documentation quality.
  • Coordinate cross-functional technical efforts manage delivery timelines and communicate risks/status to stakeholders.

• Bachelors/Masters in Computer Science Information Systems Life Sciences or related field.
• 48 years of experience with Veeva Vault including hands-on work in RIM and/or eTMF.
• Strong expertise in Vault configuration: objects fields lifecycles workflows security/permissions document types metadata and reporting/dashboards.
• Experience in incident management problem management and change/release management in validated environments.
• Solid understanding of GxP/CSV (Computer System Validation) 21 CFR Part 11 and audit/inspection processes.
• Proven track record leading technical efforts engaging stakeholders and delivering scalable compliant solutions.

• Experience with VQL API integrations SSO (SAML/Okta/Azure AD) and middleware (e.g. Boomi/Mulesoft).
• Knowledge of Clinical and Regulatory processes (study start-up TMF completeness submissions CMC RIM registrations).
• Familiarity with Jira/ServiceNow Confluence and DevOps practices for controlled deployments.
• Exposure to data migration data quality frameworks and reporting/analytics for operational insights.
• Vendor management and escalation experience with Veeva and related partners.

• Bhargav Akkula

  Senior Account Manager

  Purple Drive Technologies LLC

  Certified Minority Business Enterprise (MBE)
  Cell 1

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