Veeva Vault Configurator Clinical Suite

Veeva Vault Configuration & Enhancements

• Configure and maintain Veeva Vault R&D applications (e.g., Vault Clinical, Vault RIM, Vault Quality, Vault Safety, or related modules).
• Develop and maintain objects, fields, lifecycles, workflows, roles, picklists, document types, and other Vault components.
• Execute configuration deployments, manage change control, and maintain configuration documentation.
• Support Vault upgrades, regression testing, and feature enablement of new Veeva releases.

Business Analysis & Requirement Gathering

• Collaborate with SMEs across Clinical, Regulatory, Quality, and R&D functions to understand business processes and translate them into system requirements.
• Develop functional specifications and configuration design documents.
• Participate in workshops, UAT planning, test script preparation, and execution.

Integration & Data

• Partner with integration teams to validate interfaces between Vault and systems such as CTMS, eTMF, EDC, QMS, ERP, or RIM systems.
• Support data migration activities, including mapping, cleansing, and validation.

Compliance & Best Practices

• Ensure configurations comply with GxP, 21 CFR Part 11, Annex 11, and internal validation standards.
• Support system validation deliverables (URS, FRS, DS, IQ/OQ/PQ documentation).
• Maintain audit trails, support audits/inspections, and adhere to change control procedures.

Support & Continuous Improvement

• Provide Level 2/3 application support and troubleshoot issues.
• Identify opportunities for business process optimization and system enhancements.
• Train end users and develop SOPs, job aids, and release notes.

Required Skills:

• Bachelor's degree in Life Sciences, Computer Science, Information Systems, Engineering, or related field.
• 2 7+ years experience working with Veeva Vault in a configuration/administration role.
• Hands-on expertise in at least one Veeva R&D suite module:
• Vault Clinical (eTMF, CTMS, SSU)
• Vault RIM
• Vault Quality (QMS/Docs)
• Vault Safety
• Strong understanding of Life Sciences R&D processes (Clinical trials, Regulatory Submissions, Quality Systems, or Safety Reporting).
• Experience with validation in regulated environments (GxP, Part 11).
• Ability to create configuration documentation and technical user stories.
• Strong analytical, communication, and problem solving skills.

Preferred Qualifications

• Veeva Vault certifications (e.g., Vault Platform, Clinical Suite, RIM).
• Experience with Agile methodology, Jira, or similar tools.
• Familiarity with integration technologies (API, middleware, ETL).
• Experience supporting global Life Sciences operations (Biotech, Pharma, MedTech).

Work Site: Remote

Duration: Full-time/Subcontract

Expected Start Date: 2 Weeks

Number of Positions: 01