External System Oversight (CRO / Vendor Systems) * Oversee the validation and lifecycle control of external computerized systems used by CROs or third-party service providers, ensuring they meet internal quality and regulatory expectations. * Collaborate with other and business stakeholders to define validation requirements, risk-based controls, and deliverables for external systems that generate or process GxP data. * Ensure appropriate documentation (URS, validation packages, data flows) is in place for external systems supporting clinical studies and activities. * Ensure end-to-end Data Integrity across all GxP-relevant data flows, from initial data capture in external partner systems through all transformations, transfers, and integrations into the company-owned environments. * Ability to assess external vendor systems for compliance, validation status, and DI risk, including ...
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