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
Company Overview