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Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Lead and support site activation and regulatory/ethics document management for clinical studies from start-up to close-out. Coordinate submissions, maintain trial documentation (protocol amendments, ethics approvals), communicate with study teams and investigator sites, mentor staff, and ensure compliance with ICH/GCP, FDA and local regulations while using CTMS, eTMF and other systems.
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Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Lead site activation activities from start-up to close-out for complex clinical studies: manage ethics and regulatory submissions, coordinate site initiation, maintain lifecycle documentation, support audits/inspections, mentor colleagues, and liaise with global and local stakeholders to ensure timely approvals and quality standards.
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Lead global R&D compliance and quality management systems (QMS), driving strategy, audits, corrective actions, documentation, validation, training, and continuous improvement to ensure cGLP/cGCP/cGMP and other regulatory adherence across sites.
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Lead design and deployment of AI agents and workflow automations across Supply & Operations, coach and lead Operational Excellence (Lean/Six Sigma) projects, build OE capabilities, embed continuous improvement and AI-driven workflows into enterprise systems, and lead global OE programs and strategies in External Supply.
