{"id":3646912,"url":"https://alion.io/job/elephas-biosciences-clinical-trial-manager","title":"Clinical Trial Manager","company":{"id":3782939,"name":"Elephas Biosciences","domain":"elephas.com","url":"https://alion.io/company/elephas-biosciences","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"BambooHR","truth_index":null},"role":"Biotech","role_family":"Biotech","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":["Madison, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"CAPA","optional":false},{"name":"GCP","optional":false},{"name":"Good Clinical Practice","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-11-02T23:09:49Z","employer_posted_date":"2026-11-02","last_verified_at":"2026-11-10T04:21:58Z","board_verified":true,"closed_at":null,"days_open":7,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":7},"description":"Summary\nElephas is a growing biotechnology company located in Madison, WI seeking a talented individual to join our team as a Clinical Trial Manager. The Clinical Trial Manager leads the planning, execution, and operational oversight of clinical studies supporting Elephas' oncology diagnostic platform. The role will manage clinical studies conducted in the United States and internationally, including CRO-supported trials in India and potentially other global markets.\nThe Clinical Trial Manager will work closely with Clinical Science, Regulatory, Quality, Biostatistics, Data Management, Laboratory Operations, and other teams. The Clinical Trial Manager ensures that studies are executed with quality, efficiency, and compliance with applicable requirements. The successful candidate is an independent, collaborative clinical operations professional with demonstrated experience managing CRO-led studies.\nEssential Duties and Responsibilities\nClinical Study Management\nManage day-to-day planning, start-up, execution, and closeout for U.S. and international clinical studies, including observational and biomarker validation studies.\nDevelop and maintain study plans, timelines, enrollment milestones, risk assessments, and key operational deliverables.\nCoordinate the development, review, and implementation of protocols, amendments, study manuals, operational plans, training materials, and site-facing documents.\nSupport implementation and maintenance of electronic data capture (EDC) systems, including study-specific database readiness, data entry timelines, query resolution, and database milestones.\nMonitor study progress and proactively resolve or escalate risks affecting quality, timelines, enrollment, or study objectives.\nClinical Sample and Data Management Coordination\nCoordinate with clinical sites, CROs, central laboratories, and internal teams to support the collection, processing, shipment, tracking, and analysis of clinical biospecimens.\nSupport implementation of standardized procedures for fresh tumor biopsy collection and handling, with particular attention to specimen viability, transport requirements, and timely delivery to central laboratories.\nOversee operational processes for tracking biospecimen collection, shipment, receipt, sample adequacy, and reconciliation with clinical data.\nWork with Clinical Science, Data Management, and CRO partners to ensure timely and accurate collection of clinical outcomes, including imaging assessments, treatment response, and follow-up data.\nCRO and Vendor Oversight\nSupport CRO and vendor selection, feasibility assessments, scopes of work, onboarding, and performance evaluations.\nServe as the primary sponsor-side operational contact for international CROs, laboratories, imaging providers, and other study vendors.\nOversee CRO-managed site selection, activation, training, monitoring, recruitment, and sample collection activities.\nLead routine CRO governance meetings, track performance against agreed milestones and metrics, and drive issue resolution and corrective actions.\nBudgets and Contracts\nTrack and manage study budgets, forecasts, and vendor financial deliverables in collaboration with Clinical Development, Finance and internal stakeholders.\nCoordinate the review and negotiation of CRO agreements, study and site budgets, vendor contracts, and change orders with Legal and authorized approvers.\nMonitor spending, invoices, budget variances, and financial impacts of study scope or timeline changes.\nRegulatory, Quality, and Clinical Data Oversight\nCoordinate with Regulatory, CROs, and in-country partners to support health authority and ethics committee submissions, approvals, amendments, and ongoing reporting.\nOversee compliance with ICH-GCP, applicable country-specific requirements, study protocols, and company procedures.\nSupport inspection readiness, Trial Master File (TMF) completeness, protocol deviation management, CAPA activities, and quality risk mitigation.\nPartner with Clinical Data Management and CRO teams to oversee electronic data capture (EDC) readiness, data quality, query resolution, data reconciliation, and database milestones.\nCoordinate oversight of specimen collection, processing, and logistics with CROs and laboratory partners.\nCross-Functional Coordination and Reporting\nPartner with Clinical Science, Biostatistics, Regulatory, Quality, Laboratory Operations, Data Management, R&D, and Finance to align study requirements and deliverables.\nProvide clear, timely updates to Clinical Affairs leadership on study status, budgets, risks, critical decisions, and vendor performance.\nFacilitate effective communication and issue resolution across internal teams and international study partners.\nEducation/Experience/Skills\nBachelor's degree in life sciences, healthcare, or related field.\nMinimum of 5 years of experience in clinical research, including independent clinical trial or project management responsibilities at a sponsor or CRO.\nDemonstrated experience overseeing CROs and external vendors, including deliverables, timelines, performance, and operational escalations.\nExperience coordinating clinical study budgets, contracts, study start-up, and regulatory or ethics committee activities.\nWorking knowledge of GCP, clinical trial documentation, and clinical study quality requirements.\nCompetencies\nStrong sponsor-side clinical trial management, CRO oversight, and project leadership skills.\nAbility to manage multiple studies, budgets, priorities, and external stakeholders independently.\nWorking knowledge of ICH-GCP and international clinical trial operations and regulatory coordination.\nSound judgment in identifying operational risks, driving decisions, and escalating issues appropriately.\nExcellent written, verbal, presentation, and cross-cultural communication skills.\nAbility to interpret scientific and clinical information and collaborate with multidisciplinary teams.\nProficiency with Microsoft Office and familiarity with EDC, CTMS, and electronic TMF systems.\nPreferred Qualifications\nExperience managing international clinical studies, including studies conducted in India or other global research markets.\nExperience in oncology, solid tumors, biomarker validation, diagnostics, or observational research.\nExperience working in a sponsor-side role or a small biotechnology or diagnostics company.\nWe offer our employees competitive compensation and benefits, including paid time off, health insurance, life insurance, flexible spending accounts, a 401(k) plan, and stock options.\nDISCLAIMER\nThe preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.\nWe are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.","description_format":"text","description_chars":7177,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Health insurance","Life insurance","Stock options"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Cell & Gene Therapy","CRO & CDMO Services"],"lifecycle":[{"event":"open","at":"2026-11-02T23:09:49Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"Filed H-1B visas in the last two years","filings_12m":0,"filings_prev_12m":2,"green_card_filings_12m":0,"median_offered_wage_usd":null,"route":null,"cap_exempt":false,"checked_at":"2026-11-09T07:32:21+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":7,"expected_fill_days":36,"reasons":["conf:2","win:early"],"computed_at":"2026-11-10T06:52:35Z"},"pay":null,"html_url":"https://alion.io/job/elephas-biosciences-clinical-trial-manager","json_url":"https://alion.io/job/elephas-biosciences-clinical-trial-manager.json","meta":{"generated_at":"2026-11-10T08:13:14Z","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":19066,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-11T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":3782939},"rest":"https://alion.io/mcp/rest/get_company?id=3782939"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Felephas-biosciences-clinical-trial-manager"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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%2Felephas-biosciences-clinical-trial-manager"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Felephas-biosciences-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/elephas-biosciences-clinical-trial-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Felephas-biosciences-clinical-trial-manager"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3646912}},{"tool":"search_jobs","arguments":{"company":"elephas.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3646912},"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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