Veeva Vault Solution Architect – Clinical, Regulatory, Quality Systems

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Cristcot

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2008

💊 Pharmaceuticals

🔬 Science

💰 $10.5M Venture Round - Cristcot on 2025-06

Pharmaceuticals • Science

Cristcot is a pharmaceutical development and research company specializing in innovative drug formulations and unobtrusive drug-device combination technologies designed to improve patient adherence, reduce treatment burden, and integrate therapies into daily life. Founded in 2008 and headquartered in Austin, Texas, Cristcot provides clinical research design and execution, novel formulation and delivery engineering, specialized assay development, and regulatory strategy support; its lead investigational therapy has completed a pivotal Phase 3 study. The company focuses on solving overlooked barriers in disease management by creating intuitive, cost-effective solutions that enable more effective and confident care.

📋 Description

• Serve as the technical subject matter expert for Veeva Clinical, RIM, and Quality applications. • Define solution architecture, configuration standards, integration patterns, and technical governance for the Veeva Vault platform. • Gather and analyze business, technical, data, security, and regulatory requirements and translate them into scalable solution designs. • Lead requirements workshops, architecture sessions, design reviews, and technical decision-making with business and technology stakeholders. • Design and oversee integrations between Veeva Vault and clinical, regulatory, quality, enterprise, and data platforms. • Provide technical oversight for system implementations, enhancements, upgrades, releases, and application lifecycle activities. • Partner with development and implementation teams to review technical designs, APIs, data mappings, migration approaches, and custom components. • Recommend the effective use of standard Veeva capabilities to minimize unnecessary customization and improve maintainability. • Support Computer Software Assurance and Computer System Validation activities, including risk assessments, validation planning, testing, traceability, and change control. • Ensure solutions support applicable requirements, including GxP, 21 CFR Part 11, EU Annex 11, data integrity, security, privacy, records retention, and audit trail requirements.

🎯 Requirements

• Bachelor’s degree in Information Technology, Computer Science, Engineering, Life Sciences, or a related field. • At least 5 years of experience implementing, architecting, or supporting Veeva Vault solutions in the pharmaceutical, biotechnology, medical device, or life sciences industry. • Strong understanding of Veeva Vault architecture, configuration, security, workflows, object models, reporting, APIs, and integration capabilities. • Current Veeva certification or demonstrated implementation experience in relevant Veeva applications is strongly preferred. • Knowledge of GxP, FDA regulations, 21 CFR Part 11, EU Annex 11, and applicable data integrity requirements. • Ability to manage multiple priorities and work effectively across business, technical, and vendor teams in a fast-paced environment.

🏖️ Benefits

• None specified