Director, Growth and Operations (Canada) (Care Access)
Performed strict compliance verification on regional clinical operations data under federal and provincial privacy mandates while maintaining global standards including ICH-GCP and 21 CFR Part 11 data integrity requirements. Authored modular Standard Operating Procedures (SOPs) and instructional guides to standardize complex data collection workflows across decentralized teams, especially where technology access and experienced staffing were limited. Designed logic and documentation structures to ensure reliable, auditable data capture and procedural consistency. • Verified compliance of clinical operations data with Part 11 and privacy regulations • Authored SOPs and modular instructional guides for standardized data collection • Implemented workflow standards for decentralized teams • Supported data integrity through traceable, procedure-based documentation