Location: Remote
Employment Type: Full-time/Subcon
About the Role
We are seeking an experienced Veeva Vault Configurator with strong Life Sciences R&D domain knowledge to support the design, configuration, and enhancement of Veeva Vault applications across the R&D landscape (Clinical, Quality, Regulatory, Safety, or RIM). This role will work closely with business stakeholders, functional leads, and technical teams to translate requirements into scalable Vault configurations that align with industry regulations and organizational objectives.
Key Responsibilities
- 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.
- Maintain audit trails, support audits/inspections, and adhere to change control procedures.
- 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 Qualifications
- 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).
Soft Skills
- Strong stakeholder communication with both technical and non‑technical audiences.
- Ability to manage multiple priorities in a fast‑paced environment.
- Detail‑oriented with a focus on quality and compliance.
- Collaborative team player and proactive problem‑solver.