Clinical Study Manager

Job not on LinkedIn

🕒 August 18

🐎 Kentucky, New Hampshire, +10 more states – Remote

🐎 Kentucky – Remote 🗻 New Hampshire – Remote 🏖️ New Jersey – Remote 🌶️ New Mexico – Remote 🗽 New York – Remote 🌲 North Carolina – Remote 🍂 Massachusetts – Remote 🔔 Pennsylvania – Remote 🌴 South Carolina – Remote 🗿 South Dakota – Remote 🤠 Texas – Remote ☕ Washington – Remote

💵 $95k - $113k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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Aurion Biotech

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2022

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

💰 $120M Venture Round - Aurion Biotechnologies on 2022-04

Healthcare • Manufacturing • Biotechnology

Aurion Biotech is a clinical-stage company developing first-in-class regenerative cell therapies to restore vision by treating corneal endothelial disease and other causes of blindness. The company focuses on manufacturing-scale cell therapy platforms, using human donor corneal endothelial cells combined with supportive compounds (e. g. , rho-kinase inhibitor) to repopulate the corneal endothelium, reduce reliance on donor tissue, and enable less-invasive alternatives to graft-based keratoplasty. Aurion conducts global clinical trials, holds FDA Breakthrough Therapy and RMAT designations for its lead product AURN001, and aims to expand access to advanced ophthalmic care worldwide.

📋 Description

• Support clinical trial teams with operational aspects of studies across start-up, conduct, and close-out for insourced and outsourced trials • Support procurement activities, including vendor contracts and purchase orders • Support management of clinical supplies and clinical trial equipment provision and reclamation • Manage study-level documents in the Trial Master File (TMF) and support TMF audits • Generate reports from EDC, CTMS, and third-party vendor portals • Generate newsletters, newsblasts, checklists, and other site-level communications • Track and manage study data and metrics • Support data quality and site performance metrics, including query resolution and database lock readiness • Support inspection readiness activities, audits, audit report finalization, findings, and CAPAs • Collaborate with Clinical Operations, Regulatory, Quality, Medical, and CMC teams • Support Study Leads with vendor and system onboarding, training coordination, and process documentation • May support monitoring quality oversight and site engagement visits • Ensure compliance with GCP, ICH, Aurion SOPs, and CRO SOPs • Perform other duties as assigned

🎯 Requirements

• Bachelor's degree in life sciences, nursing, or a related field • 2–4 years of experience in clinical research, including exposure to clinical trial operations in a sponsor, CRO, or academic setting • Experience supporting Phase 2 or 3 clinical trials • Familiarity with study start-up, site maintenance, closeout, and inspection readiness processes • Working knowledge of ICH/GCP guidelines and clinical trial processes • Strong organizational and time management skills; detail-oriented and able to manage multiple tasks • Proficiency in Microsoft Office (Word, Excel, PowerPoint) • Experience with Canva, CTMS, TMF, EDC, and other clinical trial systems is a plus • Strong written, verbal, and interpersonal communication skills • Ability to work effectively in a team environment and across global teams and vendors • Demonstrated cultural agility and integrity, with passion for advancing transformative science • Ability to travel up to 15% • Commitment to Aurion Biotech's mission, vision, and core values • Candidates must be based in WA, MA, IN, NC, NJ, NH, NM, NY, PA, SC, SD, TX, or KY

🏖️ Benefits

• Full health insurance for employees and their families • 401(k) matching • Employee Assistance Program (EAP) • Flexible Spending Account (FSA) • Generous PTO • Paid parking • Subsidized commuter passes • In-office catered lunches • Team events • Community projects • Competitive compensation packages