Canon Medical Informatics · 3 months ago
Senior Clinical Validation Project Manager
Minnetonka, Minnesota, United States
Full-time
Onsite
Mid, Senior Level
$91K/yr - $137K/yr
5+ years expCanon Medical Informatics is a leader in health imaging informatics solutions. They are seeking a Senior Clinical Validation Project Manager to oversee the design and execution of clinical validation studies for their SaMD platform, ensuring compliance and delivering regulatory-grade evidence.
Health CareMedicalMedical DeviceSoftware
Responsibilities
Lead the full lifecycle of clinical validation programs, from proposal and feasibility assessment through protocol design, execution, analysis, and delivery of regulatory-grade evidence for submissions (e.g., FDA 510(k)/CE marking)
Build and execute project plans (scope, milestones, deliverables, timelines); proactively removing roadblocks
Manage risk registers, escalations, and dependencies
Conduct kickoff meetings, weekly status reports, retrospective meetings, and process improvement cycles
Maintain documentation for agendas, meeting minutes, action items, decision logs, and version-controlled study materials
Provide clear communication with stakeholders across Product, Regulatory and Engineering teams
Source, contract, catalog, de-identify, and curate heterogeneous datasets (≥1,000 cases/year)
Maintain a centralized dataset library with traceability, auditability, and access control
Perform data selection and readiness checks: filter datasets to meet study criteria, run subgroup analyses, and generate descriptive statistics on data distributions
Identify, evaluate, and onboard external clinical sites and principal investigators
Collaborate with Legal/Procurement Teams to draft agreements (e.g., SOWs, data-use, BAAs)
Conduct onsite and virtual visits; ensure timely data returns
Develop and deliver training materials, onboard radiologists and annotators
Oversee annotation workflows, quality checks, and adjudication processes
Prepare infrastructure (hardware/cloud), install/configure study software, and provide operational support
Provide ongoing support, troubleshooting, and feedback loops with site teams
Drive the creation, iteration, and refinement of study designs: partner with subject-matter experts, statisticians, and product/regulatory leads to shape initial proposals into finalized, approved study protocols
Scope and manage study budgets, ensuring alignment with project objectives and regulatory expectations
Collaborate with statisticians during study execution for formal performance analysis (e.g., accuracy/sensitivity/specificity, comparing ground-truth annotations to device outputs)
Draft and refine validation reports and supporting evidence for 510(k)/CE submissions
Qualification
Required
5+ years of experience in clinical validation, clinical research operations, or regulated software/medical-device programs
Demonstrated success running multi-site clinical studies and delivering submission-ready evidence
Strong data operations skills (Excel, QC pipelines, descriptive statistics); comfort with hardware/cloud setups
Experienced with keeping meticulous documentation of protocols, reports, and stakeholder communications
Familiarity with regulatory pathways (e.g., 510(k)/CE) and clinical research best practices
Preferred
Proficient in clinical research best practices, scientific literature review, and regulatory strategy, especially in the context of AI/ML-enabled imaging platforms (ex. Vitrea)
Proficient in regulatory pathways and strategy for AI/ML-enabled imaging platforms, coupled with expertise in clinical research best practices and scientific literature review
Benefits
Competitive compensation package
Flexible work hours
Work-life balance
Company
Canon Medical Informatics
Canon Medical provides a full suite of Healthcare IT solutions across the globe, helping healthcare organizations deliver exceptional care.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$5M2007-06-10Series A· $5M
Leadership Team
Tim Dawson
Chief Technology Officer
Anthony Bridge RT(R)(CT)
Sr. Global Sales Education/Partner Manager - HIT
Company data provided by crunchbase