Note: The job is a remote job and is open to candidates in USA. Boston Imaging - A Samsung Company is hiring a Clinical AI Data Manager to lead AI algorithm development initiatives from data acquisition through regulatory submission. The role coordinates clinical, engineering, regulatory, and external partners, and oversees project planning, data pipelines, compliance, and clinical data collection.
Responsibilities
- 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
- 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
- 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
- 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
Skills
- Experience in clinical project management, ideally within a medical device, health tech, or clinical AI environment
- 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
- 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
- Clinical ultrasound experience is strongly preferred
- Familiarity with ultrasound imaging workflows, terminology, and clinical applications is a significant advantage
Benefits
- 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, Hospital Indemnity, Pet, Legal, ID Theft
- Generous paid time off
- Tuition reimbursement
Company Overview