Clinical AI Data Manager

Samsung HME America Inc, dba NeuroLogica Corp.; United States; Presencial; USD 130.000 - 165.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical coverage

Dental coverage

Disability insurance

401k with company match

Health savings programs

Pet insurance

Paid time off

Tuition reimbursement

Descripción de la vacante

Samsung HME America is seeking a Clinical AI Data Manager to lead planning, coordination, and execution of AI algorithm development initiatives from data acquisition through regulatory submission. You will connect clinical stakeholders with AI R&D engineers, regulatory teams, and external partners to ensure on-time, on-budget delivery, with up to 70% travel and prior ultrasound experience preferred.

The role requires strong project management, regulatory knowledge, and data workflow

Formación

• Experience in clinical project management, ideally within a medical device or health tech environment.
• Clinical ultrasound experience strongly preferred; familiarity with ultrasound imaging workflows is advantageous.
• Working knowledge of FDA regulatory submissions (e.g., 510(k)) and IRB processes.
• Ability to manage multiple workstreams, budgets, and cross-functional stakeholders in a fast-paced environment.
• Strong communication and relationship-building skills with clinical, engineering, and legal teams.

Responsabilidades

• Own end-to-end data planning for AI algorithm development and regulatory submission.
• Coordinate between AI R&D, product, regulatory affairs, legal, and finance to drive alignment.
• Manage budgets, identify variances, and escalate risks and delays.
• Develop documentation and status reports for stakeholders.
• Oversee data collection, annotation, and quality benchmarks with clinical insights teams.
• Oversee the 510(k) data pipeline and coordinate data allocation for regulatory needs.

Conocimientos

Clinical ultrasound

Data management

Project management

Regulatory knowledge

Budget management

Cross-functional coordination

Herramientas

Excel

Word

PowerPoint

Outlook

Descripción del empleo

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Clinical AI Data Manager

Ultrasound Imaging Lab W2 Regular Full Time US

Salary Range: $130,000.00 To $165,000.00 Annually

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, o ther 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, elevate 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.
• 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 each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Education & Experience

• 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 (e.g., 510(k)) and IRB processes.
• Demonstrated ability to manage multiple concurrent workstreams, budgets, and cross-functional stakeholders in a fast-paced environment.
• Strong communication and relationship-building skills, with experience working alongside clinical, engineering, and legal teams.
• Independent problem solver and ability to communicate effectively in a team.

Computer & Analytical Skills

• Must be excellent with technology, able to present using a laptop and able demonstrate proficiency with Excel, Word, PowerPoint, Outlook, Internet Explorer, and Google Chrome
• Highly motivated individual with strong interpersonal skills
• Ability to juggle multiple projects and work effectively both independently and in teams
• Understanding of and commitment to client service
• Ability to meet and prioritize tight deadlines
• Excellent organizational skills, with high attention to detail
• Understanding of terminology and ability to share and communicate effectively within the group
• Ability to organize and prioritize tasks resulting in consistent productivity
• Ability to clearly explain protocols and instructions
• Dependable and punctual
• Ability to meet accuracy and productivity goals
• Good problem-solving skills, ability to evaluate situations and prioritize factors in decision making
• Self-motivated, utilize available resources for self-improvement and development
• Flexible: able to follow directives and accomplish tasks outside of normal duties

Physical Requirements

• Regularly lift and /or move up to 25 pounds, frequently lift and/or move up to 50 pounds
• Occasionally required to Push/pull weights of over 100 pounds when setting up/dismantling trade shows and/or maneuvering Company equipment into place for display
• Frequently required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear
• Must be able to sit and/or drive for long periods of time when travelling
• Must be able to stand for long periods of time (8-15 hours) for multiple days
• The noise level in the work environment is occasionally very loud.
• Specific vision abilities required by this job include Close vision, Distance vision, Peripheral vision, Depth perception and Ability to adjust focus

We offer a comprehensive benefit package which includes:

• 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)
• 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, Hospital Indemnity, Pet, Legal, ID Theft
• Generous paid time off, tuition reimbursement, and more!

Inclusion and Diversity Statement: We are an Equal Opportunity Employer and value diversity at all levels of the organization. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law. We are committed to providing reasonable accommodation to individuals with disabilities throughout the application and employment process. If you require assistance or accommodation, please contact Human Resources.