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Added 18 mins ago
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T45 Labs

Clinical Lead (Contract)

Remote, Canada

Remote

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Job details

Workplace: Remote
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.

WHAT YOU BRING

Required

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

The Clinical Lead will manage compassionate use trials for structural heart devices, ensuring all data and documentation meet FDA and Canadian regulatory standards. They will oversee case workflows, coordinate with clinical sites, and maintain trial master files to ensure audit readiness.

Requirements

Candidates must hold a bachelor's degree in life sciences or nursing and possess at least 7 years of experience in clinical research with a focus on regulated trials. A strong working knowledge of FDA regulations (21 CFR) and ICH GCP guidelines is essential for this role.

Skills

Clinical research
FDA regulations
Trial management
Good clinical practice
Regulatory strategy
Project management
Data management
Compassionate use
Medical devices
Research ethics board
Audit readiness
SOP development
Case report forms
Adverse event reporting
Transcatheter mitral valve repair

Visa sponsorship

Not detected in the job text

Keywords

Clinical Lead
Structural Heart
Transcatheter
Mitral Valve Repair
FDA
21 CFR Part 11
21 CFR Part 50
21 CFR Part 56
21 CFR Part 812
ICH GCP
REB
Clinical Operations
Trial Master File
SOP
CRO
ISO 14155
Health Canada
SOCRA
ACRP
Electronic Data Capture
Compassionate Use
Expanded Access
Life Sciences
Clinical Research
Regulatory Affairs

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