Lead compassionate use clinical operations for Mitria Medical in Toronto, coordinating regulated cases and maintaining FDA-ready records. Work hybrid on a six-month contract.As Mitria Medical's first Clinical Lead, you will own the clinical program outside the US. You will coordinate cases, Canadian approvals, and FDA expectations while reporting directly to the Chief Executive Officer. Independent decisions, detailed documentation, and careful timeline management are central to the assignment.Key Responsibilities:Own compassionate use plans, workflows, and timelinesCoordinate cases with physicians and site staffTrack REB submissions, amendments, and approvalsMaintain trial records for FDA inspection and auditDirect vendors and CRO support within budgetRequirements:Bachelor's degree in life sciences, nursing, or related fieldSeven or more years of regulated clinical research experienceTwo or more years in a clinical lead roleWorking knowledge of FDA rules and ICH GCPExperience supporting US submissions with international trial dataBring clinical operations leadership, FDA readiness, and Canadian REB expertise to Mitria Medical's compassionate use program.

📌 Clinical Operations Lead Toronto Contract
🏢 T45 Labs
📍 Toronto