Lead

Job description

Responsibilities • Lead clinical data integration and GxP compliant clinical system implementation projects, ensuring on-time, high-quality, and compliant delivery. • Manage project planning, tracking, risk mitigation, reporting, and stakeholder communication. • Ensure adherence to ICH-GCP, GxP, and 21 CFR Part 11 compliance across systems and processes. • Collaborate with clinical data management, EDC experts, data engineers, QA/CSV teams, and client SMEs. • Oversee data mapping, transformation logic, validation, and testing for project workflows. • Review and optimize end-to-end clinical data workflows using automation tools. • Support change management, documentation, training, and audit readiness. Qualifications • PMP certification (mandatory). • 5+ years of IT Project Management experience; exposure to digital transformation preferred. • Hands-on experience managing clinical trial data workflows and clinical data management projects. • Strong understanding of ICH-GCP, GxP, and 21 CFR Part 11 compliance requirements. • Experience with clinical data automation tools and EDC systems. Regards,