Clinical Trial Manager

🕒 September 17

🇺🇸 United States – Remote

💵 $90k - $150k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

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Noah Labs

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

⚕️ Healthcare Insurance

🧬 Biotechnology

💰 $2.6M Grant - Noah Labs on 2025-02

Healthcare • Healthcare Insurance • Biotechnology

Noah Labs is a healthcare company that empowers patients with cardiovascular conditions to live healthier, longer lives. They achieve this by developing innovative voice-based biomarkers for early detection and providing accessible remote monitoring solutions.

📋 Description

• Own operational execution of the US clinical program, including the FDA pivotal trial and randomized pragmatic trial • Oversee European MDR investigations run out of Berlin • Lead trial start-up, including site selection, agreements, budgets, IRB submissions, site initiation and training • Drive enrollment and protocol adherence across sites with investigators and site coordinators • Own the monitoring strategy and conduct remote and on-site monitoring visits • Manage contract monitors • Own study budgets, timelines and risk registers, reporting to the Chief Medical Officer • Run the operational backbone, including eTMF, EDC, data cleaning and protocol deviations • Ensure FDA BIMO and IRB audit and inspection readiness • Maintain sponsor SOPs • Support European investigations and regulatory compliance under ISO 14155 and MDR • Author and maintain SOPs and work instructions for clinical operations, monitoring and data management • Coordinate academic partners and specialist vendors • Collaborate with the CMedO, Clinical Research Lead, regulatory, product and R&D teams • Help grow the clinical team

🎯 Requirements

• Degree in life sciences, nursing, medicine, biomedical engineering or a related field • 5+ years in clinical research, including 3+ years in US FDA-regulated devices • Familiarity with SaMD clinical trials • Hands-on experience with the full IRB submission lifecycle, including preparing and submitting packages and amending documents such as the CIP and ICF • Hands-on experience taking a US multicenter trial from start-up through enrollment and closing, on the sponsor side and without a full-service CRO • Working knowledge of 21 CFR Parts 812, 50, 56 and 11, ICH-GCP, ISO 14155 and HIPAA • Practical experience with EDC and eTMF systems • Structured problem-solving and clear prioritization under shifting timelines • Strong stakeholder management across academic sites, health systems and senior KOLs • Uncompromising commitment to patient safety, data integrity and inspection readiness • Fluency in English • Authorized to work in the US

🏖️ Benefits

• Meaningful equity • Fully remote setup in the US • Up to 30% travel in the first 12 months, less thereafter • Occasional trips to the Berlin office • Direct exposure to leading US cardiology centers and the FDA Breakthrough Devices process

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