Cristcot Management Company INC
Veeva Vault Solution Architect – Clinical, Regulatory, Quality Systems (Contractor)
Remote (United States) · Contract
Sponsorship not specifiedDetected 1 day ago
Stakeholder ManagementFDA RegulatoryMedical DevicesLeadershipCommunicationGxPRegulatory Affairs
About the role
- Define solution architecture, configuration standards, integration patterns, and technical governance for the Veeva Vault platform.
- Provide technical oversight for system implementations, enhancements, upgrades, releases, and application lifecycle activities.
- Recommend the effective use of standard Veeva capabilities to minimize unnecessary customization and improve maintainability.
Responsibilities
- The Veeva Vault Solution Architect will collaborate closely with IT, Clinical Operations, Regulatory Affairs, Quality Assurance, System Owners and Business
- The Veeva Vault Solution Architect will engage with Veeva Systems and Veeva implementation and managed service partners The activities of the
- 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.
- Partner with development and implementation teams to review technical designs, APIs, data mappings, migration approaches, and custom components.
- 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.
- Develop and maintain solution architecture diagrams, technical specifications, configuration documentation, integration designs, data models, and operational procedures.
Requirements
- Bachelor's degree in Information Technology, Computer Science, Engineering, Life Sciences, or a related field.
- Experience designing integrations, interfaces, and data migrations involving Veeva Vault and other regulated enterprise systems.
- Working knowledge of software development practices, system development lifecycle methodologies, and release management.
- Experience with Computer Software Assurance, Computer System Validation, and regulated system documentation.
- Knowledge of GxP, FDA regulations, 21 CFR Part 11, EU Annex 11, and applicable data integrity requirements.
- Ability to travel up to 10%, as needed.
- Demonstrated experience with one or more of the following:
- Skills and Qualifications: Bachelor's degree in Information Technology, Computer Science, Engineering, Life Sciences, or a related field.
Nice to have
- Current Veeva certification or demonstrated implementation experience in relevant Veeva applications is strongly preferred.
Skills
- Strong analytical, technical documentation, communication, and stakeholder management skills.
Company info
- About Cristcot We are in the business of addressing the problem within the problem.
- We focus on the details and connections that other, major pharma companies have left ignored for years.
- There are better ways, better drugs and better formulations and we will make them a reality by analyzing, understanding and solving the problems within the problems.
- Job Summary Cristcot is seeking an experienced Veeva Vault Solution Architect for a 6-12-month contract engagement to provide technical leadership for the implementation, integration, optimization, and governance of Veeva Vault applications supporting Clinical, Regulatory, and Quality operations.
- The Veeva Vault Solution Architect will serve as the primary technical liaison among business stakeholders, IT, software development teams, Quality, and external implementation partners.
- This role will translate business, technical, and regulatory requirements into scalable, compliant, and maintainable solutions aligned with Cristcot's technology strategy and applicable life sciences regulations.
- The ideal candidate has deep Veeva Vault architecture and implementation experience, with expertise in the following areas:
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