Clinical AI Data Manager

Boston Imaging - A Samsung Company

. Lead planning, coordination, and execution of AI algorithm development initiatives from data acquisition through regulatory submission .

Posted 10/25/2026full-timeUnited StatesMid-LevelSenior💰 $130,000 - $165,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical project management within medical device and health tech environments, with a strong focus on AI algorithm development and regulatory submissions. Proficient in coordinating cross-functional teams and managing project budgets while ensuring compliance with FDA and IRB protocols.

Highest-signal resume keywords

Clinical Project ManagementFDA Regulatory SubmissionsIRB ProcessesData Collection ManagementCommunication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

AI Algorithm DevelopmentData Protocol DesignQuality Control ProcessesData ExtractionClinical Data Management

Soft Skills

Relationship BuildingIndependent Problem SolvingCoordination Skills

Tools & Technologies

ExcelWordPowerPointOutlookInternet ExplorerGoogle Chrome

Industry Keywords

Medical DeviceHealth TechClinical AIUltrasound Imaging510(k) Submission

About the role

Key responsibilities & impact

Lead planning, coordination, and execution of AI algorithm development initiatives from data acquisition through regulatory submission
Define project scope, milestones, timelines, and resource requirements
Coordinate AI R&D engineers, product, regulatory affairs, legal, finance, clinical stakeholders, and external partners
Manage project budgets and escalate risks, variances, and delays
Maintain feedback between clinical and engineering teams
Develop project documentation, status reports, and communication materials
Design, launch, and manage data protocol projects, including detection criteria, annotation methodology, and quality benchmarks
Coordinate data requirements with HQ R&D and SHA before data collection
Implement quality-control processes for data accuracy and clinical relevance
Oversee the 510(k) data pipeline and data allocation
Optimize data collection tools, workflows, and processes
Ensure compliance with IRB protocols, FDA feedback, and institutional policies
Maintain IRB protocols, coordinate renewals, and update protocols and contracts
Oversee data extraction and anonymization for submissions and studies
Coordinate cross-functional responses to regulatory feedback and track resolution
Lead end-to-end data collection for regulatory submissions
Build and manage clinical data-collection partnerships, including site prospecting, negotiations, agreements, and coordination with legal, administrative, and financial stakeholders
Prioritize data allocation across concurrent clinical and regulatory programs

Requirements

What you’ll need

Experience in clinical project management, ideally within a medical device, health tech, or clinical AI environment
Clinical ultrasound experience is strongly preferred; familiarity with ultrasound imaging workflows, terminology, and clinical applications is a significant advantage
Working knowledge of FDA regulatory submissions, such as 510(k)
Working knowledge of IRB processes
Ability to manage multiple concurrent workstreams, budgets, and cross-functional stakeholders in a fast-paced environment
Experience working alongside clinical, engineering, and legal teams
Strong communication and relationship-building skills
Independent problem-solving ability
Proficiency with Excel, Word, PowerPoint, Outlook, Internet Explorer, and Google Chrome
Ability to present using a laptop
Regularly lift and/or move up to 25 pounds
Frequently lift and/or move up to 50 pounds
Occasionally push/pull weights over 100 pounds when setting up/dismantling trade shows or maneuvering company equipment
Ability to sit and/or drive for long periods while travelling
Ability to stand for long periods (8–15 hours) for multiple days
Specific vision abilities: close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus

Benefits

Comp & perks

Medical (Blue Cross Blue Shield): 5 PPO Plans with up to 95% employer contribution
Dental (Blue Cross Blue Shield): 2 PPO Plans with up to 80% employer contribution
Vision (Blue Cross Blue Shield): 100% company paid
Short/Long Term Disability, Life & AD&D (The Standard): 100% company paid
401k Retirement (Fidelity): 100% company match up to 5%
Tax Deferred Health Care Savings Programs
Accident Insurance
Critical Illness Insurance
Hospital Indemnity Insurance
Pet Insurance
Legal Insurance
ID Theft protection
Generous paid time off
Tuition reimbursement