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Added 23 mins ago
L
Site Administrator, Building Construction
Ledcor
Toronto, ON
- Full-time
Supports and maintains project start-up systems and procedures including job site trailer or office, master filing system, project billings, cost accounting system, and project directory
Added 37 mins ago
HT
Financial Manager - PLM (Product Line Mgmt)
Husky Technologies
Bolton, ON
- Full-time
Title: Financial Manager - PLM (Product Line Mgmt)
Added 53 mins ago
TH
Clinical Manager, Birthing Services| Permanent Full Time
Trillium Health Partners
ON · ON, Canada
- Full-time
A visible and collaborative leader, the Manager creates clarity, builds trust, and supports teams in a fast-paced, high-volume environment. Working with physicians, midwives, nurses,…
Added 1 hour ago
AH
Administrative Support IV
Alberta Health Services
Lethbridge, AB
- Temporary
…provides specialized administrative assistance for the Home Care management teams within Assisted Living Alberta, reporting directly to the Manager of Ambulatory Clinics and Administration.…
Added 1 hour ago
NB
Chief Analyst, Capital Transformation
National Bank of Canada
Montreal, QC
- Temporary
impact on the Bank's capital management capabilities thanks to your expertise
Added 1 hour ago
NB
Senior AI Developer
National Bank of Canada
Montreal, QC
- Full-time
Within Wealth Management and Capital Markets, you’ll be part of a multidisciplinary team responsible for strategic digital platforms and will report to the Senior Manager, Asset Management.…
Added 1 hour ago
NB
Site Reliability Engineer
National Bank of Canada
Montreal, QC
- Full-time
…continuously improve processes.Within the IT Delivery, Wealth Management sector, you are part of a large team and report directly to the Senior Manager. Our team stands out for its…
Added 1 hour ago
D
Business developer - M/W
Dayuse.com
Montreal, QC
- Full-time
Education: Higher education - Business School, IAE, university (Master in International Business, Sales, Marketing, Hospitality, Tourism, Economics, Management), Sciences Po, MBA, or…
Added 3 hours ago
Staff Systems Developer Manager, AlphaNet Core SRE
Google
Waterloo, ON
Master's degree in Computer Science or Engineering.
Added 3 hours ago
IP
Clinical Operations Manager
Indigenous Perspectives Society
Vancouver, BC
- Full-time
Directly supervise the Administrative Support Coordinator, including workload management, coaching, issue management, and performance management.
Added 5 hours ago
SM
Manager, Finance, Performance & Analytics
Stevenson Memorial Hospital
Alliston, ON
- Full-time
Reporting to the Vice President, Corporate Services & Chief Financial Officer, the Manager, Finance, Performance and Analytics supports the hospital's strategic objectives, performance…
Added 6 hours ago
HT
Financial Manager - PLM (Product Line Mgmt)
Husky Technologies
Bolton, ON
- Full-time
Title: Financial Manager - PLM (Product Line Mgmt)
Added 6 hours ago
S
Finance Manager, Accounting & Financial Reporting (Hybrid)
Stryker
Hamilton, ON
- Full-time
Lead, coach and develop an engaged team of seven professionals across inventory and general accounting and Master Data. Setting clear expectations, providing regular feedback and creating…
Added 6 hours ago
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Clinical Research Manager
RI-MUHC | Research Institute of the MUHC | #rimuhc
Montreal, QC
- Full-time
…governmental guidelines and regulations, the Clinical Trial Project Manager is responsible for the operational management of multicentre clinical research studies. The Project Manager…
Added 6 hours ago
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Project Manager
RI-MUHC | Research Institute of the MUHC | #rimuhc
Montreal, QC
- Contract
The Centre for Precision Psychiatry – Quebec (CPPQ) is seeking a project manager for our large-scale longitudinal mental health research project across three clinical research sites,…
Added 7 hours ago
O
Sr. Manager Corporate Development
OpenText
Toronto, ON
- Full-time
…interesting work happens every day, in every department. The Sr. Manager, Corporate Development will play a pivotal role advising on a wide range of strategic programs, analyzing business…
Added 10 hours ago
M
RQ11817 - Project Manager/Leader - Senior
Maarut
Toronto, ON
- Contract
Develop project charters and master project plans, guide the
Added 10 hours ago
TO
Engineering Manager
Town of Pelham
Fonthill, ON
- Full-time
Reporting to the Director of Public Works, the Manager of Engineering is responsible for the leadership, planning, coordination, and delivery of municipal engineering services and…
Added 10 hours ago
NS
Quality & Patient Safety Leader - Quality & Patient Safety
Nova Scotia Health Authority
Halifax, NS
- Full-time
Reporting to the Manager, Quality Improvement & Safety, the Quality Improvement & Safety Leader will provide leadership within NSH’s overall provincial and zone programs for quality,…
Added 11 hours ago
C
Senior IT Systems Eng
Cognichip
Toronto, ON
- $150,000 to $185,000 CAD / year
- Full-time
Enterprise SaaS Upgrades: Lead the move of our applications to enterprise-grade tiers as we buy or upgrade them: SSO/SCIM, admin roles, audit logs, data controls, and clean cutover plans.
Added 11 hours ago
G
Regional Facility Manager - Remote, Vancouver
Guckenheimer
Mississauga, ON
- $120,000 to $125,000 CAD / year
- Full-time
The Regional Operations Manager provides leadership to key accounts that are Integrated Facility Services operations in North America.
Added 11 hours ago
FH
Trauma Clinical Counsellor, Indigenous Health
Fraser Health
Chilliwack, BC
- Full-time
…appropriate and feasible. As a member of the Intensive Case Management (ICM) Team, this position provides focused support to clients who identify as First Nations, Metis or Inuit and their…
Added 12 hours ago
HT
Financial Manager - PLM (Product Line Mgmt)
Husky Technologies
Bolton, ON
- Full-time
Title: Financial Manager - PLM (Product Line Mgmt)
Added 12 hours ago
AI
Procurement Support Coordinator
American Iron & Metal (AIM)
Montreal, QC
- Full-time
The Procurement Support Coordinator, reporting to Manager, Procurement Support Operations, is responsible for providing administrative and operational support to the procurement function.…
Added 12 hours ago
LM
DIRECTOR OF INFORMATION TECHNOLOGY
Lacroix Médecine Privée
Quebec, QC
- Full-time
…Strategy and Governance: Define and deploy the IT vision and master plan in line with the strategic, operational, and financial priorities of Groupe médical Lacroix. Advise senior…

T45 Labs

Clinical Lead (Contract)

Toronto, ON, Canada

Contract

Apply About employer

Applications open in a new tab.

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.

Apply About employer

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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