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T45 Labs

Clinical Lead (Contract)

Toronto, ON, Canada

Contract

Apply About employer

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Job details

Job type: Contract
Apply by: May 1, 2027
Working hours: 40 hours per week
Posting language: English
Posted: Nov 2, 2026

Original job description

CLINICAL LEAD (CONTRACT)

Company: Mitria Medical

Type: Contract

Term: January to June 2027 (about 6 months)

Hours: Full-time (about 40 hours per week)

Location: Toronto, Ontario - Hybrid

Reports to: Chief Executive Officer

About Mitria Medical

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.

About The Role

As Mitria's first Clinical Lead, you will own the clinical work for our compassionate use trials outside the US on a six-month contract. You will make sure every case produces data and records that FDA can accept, while meeting Canadian ethics rules, local approval requirements, and Good Clinical Practice (GCP). Reporting directly to the CEO, you will work autonomously, running the program day to day and making decisions independently within the plan and budget Mitria sets.

What You Will Do

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. This includes 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
Keep 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 that Mitria sets
Advise Mitria leadership on clinical risk, the FDA pathway, and resourcing
Send a short status report each week to Mitria leadership
Write a handover plan and file all records, so a permanent lead can take over in July 2027

Required

WHAT YOU BRING

Bachelor's degree in life sciences, nursing, or a related field. A master's degree is an asset
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 on your own and manage many cases at once
Legal eligibility to work in Canada, or ability to contract as a Canadian business

Preferred

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

LOCATION AND COMPENSATION

This is a hybrid contract position based in Canada, ideally near Toronto. Onsite presence is expected as needed to support compassionate use cases at clinical sites; otherwise, work is remote.

The anticipated rate for this position is C$14,000 to C$17,000 per month. Actual compensation will be determined based on experience, qualifications, geographic location, and other job-related factors. Mitria Medical is committed to fair and equitable pay practices.

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.

THIRD-PARTY RECRUITER NOTICE

We do not accept unsolicited resumes from staffing agencies or recruiters without a signed agreement in place. Any resumes submitted without such an agreement will be considered the property of Mitria Medical, and no fees will be paid if the candidate is hired. Agencies interested in submitting candidates may email careers@t45labs.com.

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More about this job

Responsibilities

Lead Mitria Medical’s compassionate use clinical program outside the United States, coordinating cases from request through close-out and ensuring regulatory compliance, reliable data, and inspection-ready records. Manage ethics submissions, consent and trial documentation, device accountability, safety reporting, vendors, leadership updates, and the transition to a permanent lead.

Requirements

Requires a bachelor’s degree in life sciences, nursing, or a related field, at least seven years of clinical research experience, and at least two years in a lead role. Candidates need working knowledge of FDA clinical investigation regulations, ICH GCP, Canadian REB processes, and audit readiness, plus experience with international trials supporting US submissions and eligibility to work or contract in Canada.

Skills

Clinical Trial Management
FDA Regulatory Compliance
Good Clinical Practice
Canadian Research Ethics Board Processes
Compassionate Use Trials
Informed Consent
Clinical Documentation
Audit Readiness
Adverse Event Reporting
Medical Device Trials
Trial Master File Management
Vendor and CRO Management
Clinical Risk Assessment
Electronic Data Capture
Clinical Operations

Visa sponsorship

Not detected in the job text

Keywords

Compassionate Use
Expanded Access
Clinical Research
Clinical Trials
FDA
21 CFR Part 11
21 CFR Part 50
21 CFR Part 56
21 CFR Part 812
FDA IDE
ICH GCP
Research Ethics Board
Canadian Regulatory Approvals
Health Canada
ISO 14155
Informed Consent
Source Documents
Case Report Forms
Trial Master File
Audit Readiness
FDA Inspection Readiness
Adverse Event Reporting
Device Accountability
Electronic Data Capture
Clinical Trial Management Systems
Standard Operating Procedures
CRO Management
Clinical Operations
Medical Devices
SOCRA

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