Veeva Vault Solution Architect – Clinical, Regulatory, Quality Systems (Contractor)

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:

• Veeva Clinical: CTMS and eTMF
• Veeva RIM: Submissions, Submissions Archive, and Publishing
• Veeva Quality: QualityDocs, QMS, Training, and LearnGxP

This is a 6-12 month 1099 contract.

Primary Relationships

• Within Cristcot: The Veeva Vault Solution Architect will collaborate closely with IT, Clinical Operations, Regulatory Affairs, Quality Assurance, System Owners and Business Process Owners Software development, integration, and data teams
• Outside Cristcot: The Veeva Vault Solution Architect will engage with Veeva Systems and Veeva implementation and managed service partners

The activities of the Veeva Solutions Architect will include, but are not limited to:

• 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.
• Develop and maintain solution architecture diagrams, technical specifications, configuration documentation, integration designs, data models, and operational procedures.
• Support data migration, system testing, user acceptance testing, deployment readiness, and production transition activities.
• Review system performance, usability, supportability, and operational effectiveness and recommend continuous improvements.
• Assess Veeva product releases and roadmap developments for potential business impact, risk, and adoption opportunities.
• Support technical governance, release management, vendor oversight, and ongoing platform standardization.

Skills and Qualifications:

• 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.
• Equivalent combinations of education, training, and relevant professional experience will also be considered. Candidates without a Bachelor's degree may qualify with a minimum of 9+ years of hands-on experience implementing, architecting, or supporting Veeva Vault solutions in the pharmaceutical, biotechnology, medical device, or life sciences industry.
• Demonstrated experience with one or more of the following:
• • Veeva Vault CTMS
  • Veeva Vault eTMF
  • Veeva RIM Submissions
  • Veeva RIM Submissions Archive
  • Veeva RIM Publishing
  • Veeva Vault QualityDocs
  • Veeva Vault QMS
  • Veeva Vault Training
  • Veeva LearnGxP
• Strong understanding of Veeva Vault architecture, configuration, security, workflows, object models, reporting, APIs, and integration capabilities.
• 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.
• Current Veeva certification or demonstrated implementation experience in relevant Veeva applications is strongly preferred.
• Strong analytical, technical documentation, communication, and stakeholder management skills.
• Ability to manage multiple priorities and work effectively across business, technical, and vendor teams in a fast-paced environment.
• Ability to travel up to 10%, as needed.