{"id":1010710,"url":"https://alion.io/job/nanopath-clinical-operations-manager","title":"Clinical Operations Manager","company":{"id":680634,"name":"Nanopath","domain":"nanopath.com","url":"https://alion.io/company/nanopath","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"B","score":75,"open_postings":6,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-11-06T05:58:05Z"}},"role":"Management","role_family":"Management","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cambridge, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":106000,"max_usd":198000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4830},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false}],"status":"live","first_seen_at":"2026-03-12T19:51:43Z","employer_posted_date":"2026-09-17","last_verified_at":"2026-11-06T09:45:12Z","board_verified":true,"closed_at":null,"days_open":238,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":238},"description":"Nanopath is developing a first-in-class in vitro diagnostics platform to transform how diseases are diagnosed. We aim to replace lengthy molecular testing workflows by bringing rapid, high-quality diagnostics closer to the patient. Our mission is to improve patient outcomes - starting with women - through a purpose-built platform that delivers actionable results within a single office visit.\nThe company is headquartered at The Engine, the premier tough technology incubator in the Kendall Square ecosystem. We are collectively committed to health equity and the design of solutions for underserved populations and low-resource settings. Corporate sustainability - both environmental and social - is at the forefront of our decision making.\nAbout the Role\nThe Clinical Operations Manager will play a critical role in the planning, execution, and oversight of Nanopath’s clinical studies. This role combines strategic clinical operations leadership withhands-on operational execution, supporting study start-up, site initiation, monitoring, and ongoing study management.\nThis individual will be joining at an exciting time in Nanopath’s trajectory, and will be responsible for our pilot studies as well as our pivotal study in support of FDA clearance.\nThis is an in-person, full-time salaried position.\nKey Responsibilities\nLead clinical study start-up and execution for a pivotal, multi-site clinical study\nOwn IRB submissions and ongoing regulatory coordination\nManage site selection, qualification, initiation, and monitoring\nServe as the primary operational point-of-contact for clinical sites and reference laboratories\nDevelop and maintain core clinical documentation and templates (e.g. case report forms, source documents, and regulatory binders) to ensure GCP compliance\nTrack site status, operational milestones, and key deliverables to ensure timely study start-up and patient enrollment\nCoordinate external clinical vendors and support contracting and budget-related communications\nTrack study progress, risks, and milestones, and lead regular status updates with internal stakeholders\nSupport development of the protocol and preparation of regulatory-facing study materials for IRB submission\nQualifications\nBachelor’s degree in life sciences, nursing, public health, or a related field (advanced degree preferred)\n5+ years of experience in clinical operations, clinical research, or clinical trial management\nDemonstrated experience with study start-up, IRB submissions, and site initiation\nHands-on experience with site monitoring (on-site and/or remote)\nStrong understanding of GCP, ICH guidelines, and clinical trial regulations\nExperience working with central labs, CROs, and research sites\nPrior involvement in leading or managing diagnostic/medical device clinical trials\nExceptional organizational skills and attention to detail\nAbility to work independently in a fast-moving, resource-lean environment\nExcellent written and verbal communication skills\nPreferred Experience\nExperience building clinical trial infrastructure and teams at early-stage companies\nDon’t meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Nanopath we are dedicated to building a diverse and inclusive workplace, so if you’re excited about this role but your past experience doesn’t align perfectly with every point in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles!\nNanopath Inc. is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.\nNanopath does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. 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