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About the Role
As Mitria’s first Clinical Lead, you will own the clinical work for compassionate use trials outside the US on a six-month contract. You will ensure every case produces data and records acceptable to the FDA, while meeting Canadian ethics rules, local approval requirements, and Good Clinical Practice (GCP). Reporting directly to the CEO, you will work autonomously, managing the program day-to-day and making decisions independently within the established plan and budget.
Responsibilities
- Own the compassionate use plan, case workflow, and timelines.
- Coordinate each case from request to close-out, with the treating physician and site staff.
- Run each case to FDA expectations so the data can support a US submission, including 21 CFR Parts 50 and 56 and, for devices, Part 812.
- Prepare and track Research Ethics Board (REB) submissions, amendments, and approvals.
- Confirm the local Canadian approvals each case needs, with Mitria regulatory advisors.
- Collect and check informed consent, source documents, and case report forms.
- Maintain records and data systems that meet FDA expectations, including 21 CFR Part 11 where electronic records apply.
- Track product shipment, receipt, use, return, and accountability at each site.
- Report adverse events and device incidents to Mitria’s safety and quality leads within the required time limits.
- Keep the trial master file ready for FDA inspection and audit.
- Write or approve SOPs, forms, and templates for compassionate use cases.
- Direct vendors and any CRO support, within budget limits.
- Advise Mitria leadership on clinical risk, the FDA pathway, and resourcing.
- Send a short weekly status report to Mitria leadership.
- Write a handover plan and file all records for a permanent lead to take over in July 2027.
Requirements
- Bachelor’s degree in life sciences, nursing, or a related field.
- 7 or more years in clinical research (sponsor, CRO, or site), with direct work on regulated trials.
- At least 2 years in a lead role, such as trial manager, project lead, or clinical operations lead.
- Working knowledge of FDA rules for clinical investigations (21 CFR Parts 11, 50, 56, and 812 or 312).
- Experience with trials outside the US whose data supports a US submission.
- Working knowledge of ICH GCP and Canadian REB processes.
- Experience with trial documentation, audit readiness, and FDA inspection readiness.
- Strong written English and strong attention to detail.
- Ability to work independently and manage many cases simultaneously.
- Legal eligibility to work in Canada, or ability to contract as a Canadian business.
- A master’s degree is an asset.
- Experience with compassionate use or expanded access, including FDA expanded access rules.
- Medical device trial experience (ISO 14155, FDA IDE).
- Knowledge of Health Canada trial authorization rules.
- Clinical research certification (for example SOCRA or ACRP).
- Experience with an electronic data capture or trial management system.
- French language skills.
- Experience with small companies or start-ups.
Skills
- Clinical research
- Regulated trials
- Trial management
- Clinical operations
- FDA regulations
- ICH GCP
- Canadian REB processes
- Trial documentation
- Audit readiness
- FDA inspection readiness
- Attention to detail
- Independent work
- Case management
- Compassionate use
- Expanded access
- Medical device trials
- Health Canada regulations
- Electronic data capture
- Trial management systems
Location
- Toronto, Ontario
- Canada
Work Type
- Contract
- Full-time
- Hybrid
- Remote
Experience Level
- 7+ years in clinical research
- 2+ years in a lead role
Education Level
- Bachelor's degree in life sciences, nursing, or a related field
- Master's degree is an asset
- Clinical research certification
Salary/Compensations
- C$14,000 to C$17,000 per month
About the Company
- Mitria Medical, a T45 Labs portfolio company, is an early-stage structural heart company developing a next-generation transcatheter solution for mitral valve repair.
- Our team brings together physician inventors with T45 Labs’ product development, operations, and clinical and regulatory strategy expertise to advance the device toward broader clinical use.
Equal Opportunity
- Mitria Medical is an Equal Opportunity Employer.
- We celebrate diversity and are committed to creating an inclusive environment for all employees.
- Employment decisions are based on qualifications, merit, and business needs.
- We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.