Validation Manager

5 days ago

Bengaluru India eClinical Solutions Full time

Job Description 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 CANDIDATE'S PROFILE Education/Language - Four-year college degree or higher preferred, analytic discipline a plus (Computer Science or Health related field) Professional Skills & Experience - 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 Technical Skills & Experience - 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.

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