Veeva vault Consultant

TCS•Marlborough, MA

2d•Onsite

About The Position

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.

Requirements

Bachelor’s/Master’s in Computer Science, Information Systems, Life Sciences, or related field.
4–8+ 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.

Nice To Haves

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.

Responsibilities

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.
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.
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.
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.
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.
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.