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 timelines
- Coordinate cases with physicians and site staff
- Track REB submissions, amendments, and approvals
- Maintain trial records for FDA inspection and audit
- Direct vendors and CRO support within budget Requirements:
- Bachelor’s degree in life sciences, nursing, or related field
- Seven or more years of regulated clinical research experience
- Two or more years in a clinical lead role
- Working knowledge of FDA rules and ICH GCP
- Experience supporting US submissions with international trial data Bring clinical operations leadership, FDA readiness, and Canadian REB expertise to Mitria Medical’s compassionate use program.

📌 Clinical Operations Lead Toronto Contract
🏢 T45 Labs
📍 Toronto