Senior Clinical Validation Project Manager

Senior Clinical Validation Project Manager

Job Category: Engineering

Requisition Number: SENIO
001605

• Posted :
  September 29, 2025
• Full-Time
• Hybrid

Showing 1 location

POSITION OVERVIEW

We are looking for a driven Senior Clinical Validation Project Manager to join our team at Canon Medical Informatics! In this role you will oversee the design and execution of high-impact clinical validation studies for Canon Medical informatics’ flagship SaMD platform. You will architect multi-site research programs, curate and qualify medical imaging datasets, and produce submission-grade scientific/clinical evidence to accelerate time-to-market for AI/ML-enabled features.

You will work cross functionally to create and refine protocols, and align regulatory strategy to deliver compliant, audit-ready results.

RESPONSIBILITIES

Program & Project Management

• 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

Data Management & Analysis

• 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

Study Design & Execution (Regulatory Documentation)

• 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

REQUIRED EDUCATION AND SKILLS

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

JOB COMPETENCIES

• Project Management - Establishes project goals, milestones, and procedures, defines roles and responsibilities, acquires project resources, coordinates projects throughout company, monitors project progress, manages multiple projects.
• Communication - Communicates well both verbally and in writing, creates accurate and punctual reports, delivers presentations, shares information and ideas with others, has good listening skills.
• Customer Focus - Builds customer confidence, is committed to increasing customer satisfaction, sets achievable customer expectations, assumes responsibility for solving customer problems, ensures commitments to customers are met, solicits opinions and ideas from customers, responds to internal customers.
• Adaptability/Flexibility - Adapts to change, is open to new ideas, takes on new responsibilities, handles pressure, adjusts plans to meet changing needs.
• Meeting Management - Holds appropriate…