{"id":2985329,"url":"https://alion.io/job/noah-labs-clinical-trial-manager","title":"Clinical Trial Manager","company":{"id":680245,"name":"Noah Labs","domain":"noah-labs.com","url":"https://alion.io/company/noah-labs","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Join","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":null,"employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":{"label":"CET","utc_offset_min":1,"utc_offset_max":1},"hiring_geo_confidence":"explicit","locations":[],"countries":[],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":90000,"max":150000,"currency":"USD","period":"year","gross":null,"usd_annual":150000},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Good Clinical Practice","optional":false},{"name":"HIPAA","optional":false},{"name":"FDA 510(k)","optional":true}],"status":"live","first_seen_at":"2026-09-16T19:41:36Z","employer_posted_date":"2026-09-16","last_verified_at":"2026-10-28T21:14:13Z","board_verified":true,"closed_at":null,"days_open":42,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":42},"description":"Noah Labs is a digital cardiology start-up, based in Berlin and Boston. We already run a CE-marked remote patient monitoring platform deployed across Europe, and we’re now developing Noah Labs Vox, a voice-based Software as a Medical Device that detects worsening heart failure from short daily smartphone recordings.\nVox holds FDA Breakthrough Device Designation, with our FDA pivotal trial underway across 15+ sites in the US, Canada and Europe. We partner with leading academic centers and health systems across Europe and the US, including Charité, the Mayo Clinic, Duke, and Harvard.\nEverything we do is anchored in one goal: helping patients with heart failure live longer, healthier lives.\nTasks\nThe role\nAs Vox is now gaining traction and momentum in the US, you will own the operational execution of our US clinical program - the FDA pivotal trial (15+ sites, De Novo submission) and a randomized pragmatic trial embedded in routine care, as well as oversight of our European MDR investigations run out of Berlin.\nWe don't work with a full-service CRO. This means you're not managing a vendor relationship, you're building the function itself, the one Noah Labs scales on after clearance. You'll manage sites directly, coordinate the academic partners and specialist vendors who provide independent trial functions, and help grow the clinical team as we go. You work directly with our CMedO, Clinical Research Lead, regulatory, product and R&D. You report directly to our CMedO and work face-to-face with investigators at leading US cardiology centers and inside the FDA dialogue that's shaping what a new device category even looks like.\nIf you like to bring structure to ambiguity and are comfortable making decisions amid uncertainty, this role is built for you.\nIn this role you will\nLead trial start-up including site selection, agreements, and budgets, IRB submissions, site initiation and training\nDrive enrollment and protocol adherence across sites in close partnership with investigators and site coordinators\nOwn the monitoring strategy and personally conduct monitoring visits, both remote and on-site, in addition to managing any contract monitors\nOwn study budgets, timelines and risk registers, reporting directly to the Chief Medical Officer\nRun the operational backbone: eTMF, EDC, data cleaning, and protocol deviations\nEnsure audit and inspection readiness (FDA BIMO, IRB) and maintain sponsor SOPs’\nSupport the European investigations and regulatory compliance (ISO 14155, MDR)\nAuthor and maintain SOPs and work instructions (WIs) for clinical operations, monitoring, and data management\nRequirements\nWhat we're looking for\nDegree in life sciences, nursing, medicine, biomedical engineering or a related field\n5+ years in clinical research, including 3+ years in US FDA-regulated devices\nFamiliarity with SaMD clinical trials\nHands-on experience with the full IRB submission lifecycle: preparing and submitting packages, then amending documents like the CIP and ICF as the protocol changes.\nHands-on experience taking a US multicenter trial from start-up through enrollment, and closing, on the sponsor side and without a full-service CRO\nWorking knowledge of 21 CFR Parts 812, 50, 56 and 11, ICH-GCP, ISO 14155 and HIPAA; practical experience with EDC and eTMF systems\nStructured problem-solving and clear prioritization under shifting timelines\nStrong stakeholder management across academic sites, health systems and senior KOLs\nUncompromising on patient safety, data integrity and inspection readiness\nFluency in English\nAuthorized to work in the US\nNice to have\nCardiology or heart failure trials; pragmatic or health-system-embedded trials.\nApp-based or remote monitoring studies (patient onboarding, adherence, technical support)\nContribution to a De Novo, 510(k) or PMA clinical evidence package\nAdvanced academic degree (e.g. MSc)\nThings to be aware of\nThis is a remote, US-based role with regular presence at study sites - up to 30% travel in the first 12 months, less thereafter, plus occasional trips to our Berlin office. Working hours bridge US and Berlin time zones.\nBenefits\n $90-150K depending on experience, plus meaningful equity\nBring a first-in-class digital biomarker through FDA clearance and into routine care\nA dynamic startup with exceptional talent from Harvard, TUM, Meta and Stanford\nFully remote setup in the US with regular visits to our Berlin headquarters\nDirect exposure to leading US cardiology centers and the FDA Breakthrough Devices process\nApply Now and be a part of our mission to transform heart failure management through cutting-edge technology and compassionate care.","description_format":"text","description_chars":4639,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":["Equity"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Cardiovascular Devices","Consumer Health Apps"],"lifecycle":[{"event":"open","at":"2026-10-21T08:17:56Z"}],"visa":[],"liveness":{"score":36,"band":"fade","label":"Fading","p_open":1,"p_active":0.649,"p_room":0.55,"age_days":41,"expected_fill_days":37,"reasons":["conf:2","win:tail"],"computed_at":"2026-10-28T05:59:10Z"},"pay":{"stated_usd_annual":150000,"is_top_pay":false},"html_url":"https://alion.io/job/noah-labs-clinical-trial-manager","json_url":"https://alion.io/job/noah-labs-clinical-trial-manager.json","meta":{"generated_at":"2026-10-28T22:10:24Z","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":29938,"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":680245},"rest":"https://alion.io/mcp/rest/get_company?id=680245"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fnoah-labs-clinical-trial-manager"},{"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%2Fnoah-labs-clinical-trial-manager"},{"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%2Fnoah-labs-clinical-trial-manager"},{"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/noah-labs-clinical-trial-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fnoah-labs-clinical-trial-manager"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2985329}},{"tool":"search_jobs","arguments":{"company":"noah-labs.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2985329},"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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