Imaging Manager, Clinical Operations

HistoSonics, Inc.; Stati Uniti; Remoto; USD 140.000 - 190.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

401(k)

Descrizione del lavoro

HistoSonics, Inc. is seeking an Imaging Manager, Clinical Operations to lead imaging across preclinical and clinical programs in a remote-capable role within the contiguous United States.

You will oversee ultrasound, MR, CT, fluoroscopy, and other modalities, manage core labs, vendors, and SOP governance, ensuring data readiness for regulatory submissions. You’ll design imaging components in study protocols, drive quality control, support audits, and coordinate with sponsors, CROs, and internal

Competenze

• 10+ years hands-on experience in preclinical/clinical imaging
• Experience in regulated research environments (medical devices/biotech/CRO)
• Proven SOP/protocol author and staff training experience
• Vendor lab management including reviewing SOWs and budgets
• Strong data integrity and多-system data flow experience
• Excellent written and verbal communication, able to present to diverse audiences
• Proficiency with Microsoft Office suite

Mansioni

• Lead imaging modalities technical resource across studies.
• Oversee image acquisition and quality control for safety and performance studies.
• Design imaging components of study protocols with study leads and R&D teams.
• Author and maintain SOPs for imaging procedures and data handling.
• Support audits related to imaging data and procedures.
• Act as primary imaging contact for stakeholders and CROs.
• Communicate progress and constraints clearly to cross-functional teams.
• Manage imaging repository governance and user access levels.
• Plan imaging software updates, migrations, vendor transitions, and downtime risk.
• Monitor core lab performance against SOWs and timelines.
• Track imaging submissions across sites and ensure data integrity.

Conoscenze

Imaging modalities

Vendor management

SOP authoring

Data integrity

Regulatory readiness

Project management

Communication

MS Office

Formazione

Bachelor’s degree in life sciences

Strumenti

Core lab management

Descrizione del lavoro

HistoSonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non-invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development. In addition to its current liver tumor indication, HistoSonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women’s health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties.

We offer an exciting work culture where cutting-edge science meets real-world application, and each team member’s contribution is important to our success in ensuring our physicians and their patients get what they need most.

Location: Remote - Contiguous United States

Travel: 10-20%

Position Summary

The Imaging Manager, Clinical Operations will lead imaging operations in support of our medical device research and development programs, spanning both preclinical studies and pre-market/postmarket clinical trial imaging data management. This individual will serve as the organization's subject-matter expert across multiple imaging modalities including ultrasound, MR, CT, fluoroscopy, angiography, and others. This individual will also manage, imaging platforms, vendors, and ensure data readiness for regulatory submission. This is a hybrid technical/operational leadership role. The ideal candidate combines hands‑on imaging expertise with strong vendor and project management skills: equally comfortable evaluating an image read for quality, negotiating a core lab statement of work, or troubleshooting a repository access issue.

Key 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.

Qualifications And 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

We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.