Note: The job is a remote job and is open to candidates in USA. HistoSonics, Inc. is hiring an Imaging Manager, Clinical Operations to lead imaging operations for preclinical studies and pre-market and postmarket clinical trials. The role oversees imaging quality, data management and integrity, vendor and core lab performance, and readiness of imaging data for regulatory submission.

Responsibilities

• Serve as the lead technical resource for all imaging modalities
• Oversee image acquisition and quality control, in support of device safety and performance studies
• Partner with study leads and R&D core teams to design imaging components of study protocols
• Author, revise, and maintain SOPs governing imaging procedures, equipment use, and data handling
• Support internal and external (sponsor, regulatory) audits related to imaging data and procedures
• Act as the primary imaging point of contact for internal stakeholders and CROs
• Communicate study progress, imaging findings, and technical constraints clearly to cross-functional and non-technical audiences
• Own the governance of the imaging repository: manage user access levels
• Coordinate and plan for imaging software/platform updates, migrations, and vendor transitions, proactively managing read-delay and downtime risk
• Manage day-to-day core lab and imaging vendor performance against contracted deliverables
• Ensure required vendor documentation is complete and current: project plans, charters, image acquisition guidelines (IAGs), and training manuals
• Review statements of work (SOWs) and budgets for imaging core labs
• Track imaging submissions across all clinical study sites
• Monitor submission timelines against study milestones; proactively flag risk to deadlines
• Keep study teams informed of submission issues, delays, or timeline slips
• Verify that core lab activities are being conducted in accordance with study protocol requirements
• Track core lab turnaround times for reads, reports, and data transfers, and drive corrective action when performance lags
• Coordinate imaging data flow from sites → core lab → study database, ensuring a clean, traceable chain of custody
• Track missing, delayed, imaging and drive resolution with sites and vendors
• Ensure data integrity throughout the imaging data lifecycle
• Monitor image reads for quality and consistency across readers/sites

Skills

• Bachelor's degree in a life sciences, biomedical engineering, or related field (or equivalent experience)
• 10+ years of hands-on experience in preclinical/clinical research, with substantial direct experience across multiple imaging modalities
• Demonstrated experience in a regulated research environment, ideally within medical devices, biotech, or a CRO setting
• Proven track record authoring SOPs and protocols, and training/mentoring technical staff
• Experience managing vendor core labs, and/or sponsor relationships, including reviewing statements of work and budgets
• Strong data integrity practices
• Comfort managing data flow and documentation across multiple systems/stakeholders (sites, core lab, internal database), including tracking timelines and escalating risk
• Excellent written and verbal communication skills; comfortable presenting technical findings to cross-functional and external audiences
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams)

Benefits

• For full-time employees: health insurance
• For full-time employees: dental insurance
• For full-time employees: vision insurance
• For full-time employees: life insurance
• For full-time employees: short-term disability insurance
• For full-time employees: long-term disability insurance
• For full-time employees: 401(k)
• For full-time employees: paid time off
• Remote - Contiguous United States

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