Teams at Pfizer

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.

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.

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.