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. * Contribute to the development, implementation, and continuous improvement of DI practices aligned with ICH E6(R3) expectations and EMA guidance on sponsor oversight of computerized systems * Bachelor's Degree required, Master's degree preferred (IT, Engineering, Life Sciences, or related field). * Solid knowledge of GLP, GCP, GVP and GRA regulatory frameworks and associated expectations for computerized systems (e.g., OECD GLP, ICH E6(R3), EU GVP Module I/IX). * Strong understanding of Computerized System Validation (CSV) principles, including risk-based approaches and system lifecycle activities. * Ability to assess external vendor systems for compliance, validation status, and DI risk, including interpretation ...
more