Job opportunity
Clinical Operations Lead Toronto Contract
T45 Labs
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.
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Apply on source site 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.
#J-18808-Ljbffr