Clinical AI Data Manager

Clinical AI Data Manager

Travel: This position requires up to 70% travel which may include some weekends

Who We Are

Samsung HME America (Healthcare and Medical Equipment) is Samsung’s U.S. medical imaging organization, delivering advanced diagnostic solutions across Ultrasound, Digital Radiography, and Computed Tomography. We lead nationwide sales, marketing, service, and distribution of Samsung’s imaging technologies, partnering with healthcare providers to strengthen diagnostic capabilities, streamline clinical workflows, and support better patient care. Samsung HME America also serves as the global manufacturing center for Samsung’s mobile Computed Tomography (mCT) business, leading the development of advanced CT systems used by healthcare providers worldwide.

Backed by Samsung Electronics’ global technology leadership, our teams work closely with clinicians to translate real-world challenges into innovative imaging solutions. Our culture combines a sense of urgency, customer focus, and clinical collaboration to advance the future of medical imaging.

Role Description

The Clinical AI Project Manager leads the planning, coordination, and execution of AI algorithm development initiatives from data acquisition through regulatory submission. This role serves as the central hub connecting clinical stakeholders, AI R&D engineers, regulatory teams, and external partners, ensuring projects are delivered on time, within budget, and in full compliance with applicable requirements. Clinical ultrasound experience is preferred.

Key duties and responsibilities, other duties may be assigned:

Project & Program Management

• Own end-to-end project data planning for AI algorithm development, including defining scope, milestones, timelines, and resource requirements across all phases from data collection through regulatory submission.
• Serve as the primary point of coordination between AI R&D engineers, product team, regulatory affairs, legal, and finance, driving alignment and removing blockers across workstreams.
• Manage and track project budgets; proactively identify variances, escalate risks and delays to management.
• Establish and maintain a continuous feedback loop between clinical and engineering teams, ensuring clinical relevance is preserved throughout algorithm development.
• Develop and maintain project documentation, status reports, and communication artifacts for internal and external stakeholders.

Data Pipeline & Annotation

• Design, launch, and manage protocol projects, defining detection criteria, annotation methodology, and quality benchmarks in collaboration with AI R&D engineers and clinical insights team.
• Communicate and approve data needs and requirements for each AI feature in alignment with HQ R&D and SHA prior to starting data collection.
• Implement quality control processes to ensure data accuracy and clinical relevance.
• Oversee the 510(k) data pipeline; review results iteratively with the AI R&D team and coordinate data allocation to meet ongoing clinical and regulatory needs.
• Continuously evaluate and optimize data collection tools, workflows, and processes to improve throughput and reduce cost.

Regulatory Compliance & Operations

• Ensure all data collection activities comply with applicable regulations and ethical requirements, including IRB protocols, FDA feedback, and institutional policies.
• Maintain and align active IRB protocols, tracking costs, coordinating timely renewals, and updating protocols and contracts as regulatory or study needs evolve.
• Oversee data extraction and anonymization processes to meet submission and study requirements, ensuring data integrity throughout.
• Action feedback from regulatory bodies (e.g., FDA) promptly, coordinating cross-functional responses and tracking resolution to closure.

Clinical Partnerships & Data Collection

• Lead end-to-end data collection for all regulatory submissions, coordinating across sites, teams, and timelines.
• Build and manage a pipeline of data collection partners: prospect new clinical sites, lead negotiations, formalize site agreements, and coordinate with legal, administrative, and financial stakeholders.
• Serve as the central coordinator for data allocation decisions, prioritizing incoming data to satisfy all concurrent clinical and regulatory program needs.

Qualifications and Requirements:To perform this job successfully, an individual must be able to perform eac…