{"id":3004888,"url":"https://alion.io/job/histosonics-imaging-manager-clinical-operations","title":"Imaging Manager, Clinical Operations","company":{"id":1945754,"name":"HistoSonics","domain":"histosonics.com","url":"https://alion.io/company/histosonics","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"staff","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":[],"countries":[],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":120000,"max":150000,"currency":"USD","period":"year","gross":null,"usd_annual":150000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false},{"name":"Outlook","optional":false}],"status":"live","first_seen_at":"2026-10-19T19:47:00Z","employer_posted_date":"2026-10-19","last_verified_at":"2026-10-28T16:12:04Z","board_verified":true,"closed_at":null,"days_open":8,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":8},"description":"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.\nWe 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.\nLocation: Remote - Contiguous United States\nTravel: 10-20%\nPosition Summary:\nThe 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.\nKey Responsibilities:\nServe as the lead technical resource for all imaging modalities.\nOversee image acquisition and quality control, in support of device safety and performance studies.\nPartner with study leads and R&D core teams to design imaging components of study protocols.\nAuthor, revise, and maintain SOPs governing imaging procedures, equipment use, and data handling.\nSupport internal and external (sponsor, regulatory) audits related to imaging data and procedures.\nAct as the primary imaging point of contact for internal stakeholders and CROs.\nCommunicate study progress, imaging findings, and technical constraints clearly to cross-functional and non-technical audiences.\nOwn the governance of the imaging repository: manage user access levels. \nCoordinate and plan for imaging software/platform updates, migrations, and vendor transitions, proactively managing read-delay and downtime risk.\nManage day-to-day core lab and imaging vendor performance against contracted deliverables.\nEnsure required vendor documentation is complete and current: project plans, charters, image acquisition guidelines (IAGs), and training manuals.\nReview statements of work (SOWs) and budgets for imaging core labs.\nTrack imaging submissions across all clinical study sites.\nMonitor submission timelines against study milestones; proactively flag risk to deadlines.\nKeep study teams informed of submission issues, delays, or timeline slips.\nVerify that core lab activities are being conducted in accordance with study protocol requirements.\nTrack core lab turnaround times for reads, reports, and data transfers, and drive corrective action when performance lags.\nCoordinate imaging data flow from sites → core lab → study database, ensuring a clean, traceable chain of custody.\nTrack missing, delayed, imaging and drive resolution with sites and vendors.\nEnsure data integrity throughout the imaging data lifecycle.\nMonitor image reads for quality and consistency across readers/sites.\nQualifications and Skills:\nBachelor's degree in a life sciences, biomedical engineering, or related field (or equivalent experience).\n10+ years of hands-on experience in preclinical/clinical research, with substantial direct experience across multiple imaging modalities.\nDemonstrated experience in a regulated research environment, ideally within medical devices, biotech, or a CRO setting.\nProven track record authoring SOPs and protocols, and training/mentoring technical staff.\nExperience managing vendor core labs, and/or sponsor relationships, including reviewing statements of work and budgets.\nStrong data integrity practices.\nComfort managing data flow and documentation across multiple systems/stakeholders (sites, core lab, internal database), including tracking timelines and escalating risk.\nExcellent written and verbal communication skills; comfortable presenting technical findings to cross-functional and external audiences.\nProficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams).\nBenefits: 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.\nWe 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.","description_format":"text","description_chars":5318,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":["Vision insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Robotics"],"lifecycle":[{"event":"open","at":"2026-10-21T13:26:19Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 4","filings_12m":4,"filings_prev_12m":1,"green_card_filings_12m":0,"median_offered_wage_usd":127500,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":8,"expected_fill_days":58,"reasons":["conf:3","win:early"],"computed_at":"2026-10-28T05:59:10Z"},"pay":{"stated_usd_annual":150000,"is_top_pay":false},"html_url":"https://alion.io/job/histosonics-imaging-manager-clinical-operations","json_url":"https://alion.io/job/histosonics-imaging-manager-clinical-operations.json","meta":{"generated_at":"2026-10-28T18:32:04Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":25350,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-29T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1945754},"rest":"https://alion.io/mcp/rest/get_company?id=1945754"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fhistosonics-imaging-manager-clinical-operations"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fhistosonics-imaging-manager-clinical-operations"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fhistosonics-imaging-manager-clinical-operations"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/histosonics-imaging-manager-clinical-operations\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fhistosonics-imaging-manager-clinical-operations"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3004888}},{"tool":"search_jobs","arguments":{"company":"histosonics.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3004888},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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