Process-oriented Senior Clinical Data Operations Manager successful at leading process improvement and global harmonization initiatives across data management, programming, biostatistics and medical writing areas. Implement workflow automation and bedside data capture (eSource) in Phase I clinics. Lead operational teams in support of clinical trials for both pharmaceutical and contract research organizations. Areas of expertise:
• Globalization of Operations
• Harmonization of Process and Standards
• Implementation of EDC
• Successful Customer Interactions
• Process Improvement (Lean Sigma)
• Submission data (CDISC formats)
• Workflow and bedside EDC Phase I Clinics