Imaging Manager, Clinical Operations

HISTOSONICS INC• US,

4d•$120,000 - $150,000•Remote

About The Position

The Imaging Manager, Clinical Operations leads imaging operations for HistoSonics’ medical device research and development programs, including preclinical studies and pre-market and postmarket clinical trial imaging data management. The role serves as a subject-matter expert across imaging modalities such as ultrasound, MR, CT, fluoroscopy, and angiography, and manages imaging platforms and vendors while ensuring data readiness for regulatory submissions. It combines hands-on imaging expertise with technical and operational leadership, vendor management, and project management.

Requirements

Bachelor's degree in life sciences, biomedical engineering, or a related field, or equivalent experience.
At least 10 years of hands-on experience in preclinical or clinical research, with substantial direct experience across multiple imaging modalities.
Experience in a regulated research environment, ideally within medical devices, biotech, or a CRO.
Experience authoring SOPs and protocols and training or 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 and stakeholders, including tracking timelines and escalating risks.
Excellent written and verbal communication skills, including presenting technical findings to cross-functional and external audiences.
Proficiency with Microsoft Office, including Word, Excel, PowerPoint, Outlook, and Teams.

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 and 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 to cross-functional and non-technical audiences.
Govern the imaging repository, including managing user access levels.
Coordinate imaging software and platform updates, migrations, and vendor transitions, proactively managing read-delay and downtime risks.
Manage day-to-day core lab and imaging vendor performance against contracted deliverables.
Ensure vendor documentation is complete and current, including project plans, charters, image acquisition guidelines, and training manuals.
Review statements of work and budgets for imaging core labs.
Track imaging submissions across clinical study sites and monitor submission timelines against study milestones.
Proactively flag deadline risks and keep study teams informed of submission issues, delays, or timeline slips.
Verify that core lab activities comply 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 through the core lab to the study database, ensuring a clean, traceable chain of custody.
Track missing or delayed imaging data and drive resolution with sites and vendors.
Ensure data integrity throughout the imaging data lifecycle.
Monitor image reads for quality and consistency across readers and sites.