Teams at Xenon Pharmaceuticals Inc.

Supports clinical operations teams in conducting pharmaceutical clinical trials through document review, study start-up, regulatory tracking, eTMF maintenance, trial metrics, sample and supply coordination, vendor and CRO collaboration, invoice processing, meeting support, quality control, audit preparation, and timeline and budget monitoring.

Provides GCP and GLP quality assurance support for early-stage clinical programs, including quality planning, risk assessments, audits, inspection readiness, compliance consultation, training, CAPA evaluation, root cause analysis, and regulatory inspection support. Collaborates with cross-functional stakeholders to identify and escalate quality issues, maintain data integrity, and advance GLP/GCP quality strategies across pharmaceutical R&D programs.

Manages end-to-end clinical supply activities, including study-specific planning, forecasting, packaging, labeling, distribution, inventory monitoring, accountability, returns, and destruction. Coordinates with clinical, regulatory, quality, CMC, supply chain, and external vendors to ensure compliant and timely site supply. Oversees IXRS specifications and monitoring, vendor budgets, supply releases, documentation, KPI reporting, root-cause analysis, and continuous improvement across international clinical trials.