Clinical Data Management leader with over 16 years of global experience in Phase I–IV clinical trials across diverse therapeutic areas. Expertise in data strategy, project leadership, regulatory compliance (ICH-GCP, 21 CFR Part 11), and vendor oversight. Proven success in enhancing data quality, improving process efficiency, and delivering high-impact results in cross-functional and multicultural environments. Strong command of industry standards (CDASH, SDTM), risk-based monitoring, and clinical trial operations.
- Clinical Data Management Strategy & Execution
- Cross-functional Team Leadership & People Management
- Regulatory Compliance (ICH-GCP, 21 CFR Part 11)
- Stakeholder & Vendor Relationship Management
- SDTM, CDASH, EDC Systems & CRF Design
- Risk & Quality Management
- Budget & Resource Planning
- SOP Development & Process Optimization
- Global Trial Oversight (Phase I–IV)
- Database Design, UAT & Data Reconciliation