Validation Manager

Overview

Validation Manager is a client-facing role, supporting pharmaceutical and life sciences clients with the validation of the elluminate® Clinical Data Cloud platform. This role is critical in ensuring clients achieve and maintain compliance with global regulatory requirements during the deployment and use of elluminate.

As a trusted advisor, you will guide clients through validation planning, execution, and documentation, while ensuring alignment with best practices and industry standards.

Key Tasks & Responsibilities

• Act as the primary validation subject matter expert (SME) during client implementations of elluminate.
• Provide strategic guidance to clients on Computer System Validation (CSV) and GxP compliance for elluminate modules (e.g., Data Central, Mapper, Reviewer, RBQM).
• Lead client workshops to define validation scope, develop risk-based validation plans, and align expectations for documentation and responsibilities.
• Collaborate closely with internal product, implementation, and quality teams to align platform capabilities with client-specific validation requirements.
• Create and/or review validation deliverables for clients, including Validation Plans, Risk Assessments, Requirements Traceability Matrices (RTMs), IQ/OQ/PQ protocols, and Validation Summary Reports.
• Support clients during regulatory audits and inspections related to elluminate use and validation.
• Maintain a deep understanding of elluminate functionality and updates to anticipate validation impact and provide proactive client guidance.
• Facilitate knowledge transfer and training to client stakeholders on validation processes and regulatory expectations.
• Contribute to the development and refinement of validation templates, tools, and frameworks used in client engagements.
• Other duties as assigned
  
  

• Four-year college degree or higher preferred, analytic discipline a plus (Computer Science or Health related field)
  
  

• Strong consulting, communication, and relationship management skills with an ability to influence and educate clients.
• Ability to manage multiple client projects simultaneously while maintaining a high standard of quality and compliance.
• Excellent knowledge of English; verbal and written communication skills
  
  

• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
• 5+ years of experience in Computer System Validation (CSV) in a GxP-regulated environment, with at least 2+ years in a client-facing role.
• Proven experience supporting validation of cloud-based/SaaS clinical data platforms (e.g., elluminate, Medidata Rave, Veeva, InForm).
• Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology preferred
• Understanding of clinical data workflows, data integration, and analytics in regulated environments.