Teams at ClinChoice

Prepare, review, and support medical device registration submissions and post-market activities per Health Canada. Manage document extraction, change control, labeling, authorizations, and tracking. Ensure cGDP compliance, coordinate cross-functional teams, respond to inquiries, maintain regulatory dossiers, and support tactical issue resolution.

Lead data management for clinical trials including database setup, eCRF specification, validation/edit checks, testing, data review/reconciliation, SAE reconciliation, database lock/unlock, vendor data transfers, training, and DM documentation to meet timelines and quality standards.

Develop, validate, and maintain statistical programs (TLFs) using SAS and R. Perform data manipulation, analysis, visualization, and QC. Collaborate with biostatisticians and data management, ensure CDISC and regulatory compliance, and support submission documentation.