Senior Clinical Trials Manager – European Medical Device Studies

🕒 Agosto 25

🗽 New York – Remoto

🗽 New York – Remote

💵 $158.000 - $214.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

👻 Score fantasma 0%

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T45 Labs

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2022

🏥 Saúde

💼 Consultoria

🏭 Manufatura

Healthcare • Consulting • Manufacturing

A T45 Labs é uma desenvolvedora e fundo de capital de risco com sede no Vale do Silício, que desenvolve e financia tecnologias médicas cardiovasculares de próxima geração e minimamente invasivas. A empresa incentiva e financia empresas do portfólio que trabalham em terapias e dispositivos avançados — incluindo balões com revestimento duplo de nanopartículas, redutores de seio coronário e imagem intravascular sem fio — com foco no avanço clínico, marcos regulatórios e saídas estratégicas. A firma combina desenvolvimento de produtos MedTech, estratégia comercial e experiência em mercados de capitais para promover empresas em direção à comercialização.

Descrição

• Lead operational planning and execution of multi-country European medical device clinical trials from startup through study closeout • Develop and execute study startup strategy and maintain accountability for site activation across European sites • Develop and maintain study timelines, milestones, and operational deliverables • Lead enrollment forecasting, study metrics, and operational reporting • Identify operational risks and implement mitigation plans • Ensure execution aligns with protocols, timelines, budgets, business objectives, European regulatory and ethics requirements, and study plans • Serve as primary operational contact for CROs, vendors, consultants, and external study partners • Manage vendor deliverables, timelines, communications, budgets, and performance • Maintain study-level oversight of CROs, vendors, site budgets, and contracts • Coordinate operational activities across US and European vendors, sites, and stakeholders • Oversee study documentation, TMF quality, and inspection readiness • Ensure compliance with SOPs, GCP, FDA regulations, ISO 14155, EU MDR 2017/745, and quality-system requirements • Lead risk identification, issue escalation, and mitigation planning • Oversee CAPA follow-up and resolution • Drive resolution of study-level operational challenges • Partner with Clinical Affairs, Regulatory, Quality, Engineering, and other internal stakeholders • Lead study team meetings and operational reviews across US and European time zones • Provide leadership with study updates, operational insights, enrollment forecasts, and risk assessments • Drive alignment across internal teams, vendors, and clinical sites • Ensure consistent study-process execution across participating European countries and sites

🎯 Requisitos

• 7+ years of experience managing medical device clinical studies, including sponsor-side clinical trial management experience at an early-stage medical device startup company • Sponsor-side experience required; exclusively CRO-based experience does not meet the requirement • Experience managing multi-country European medical device clinical studies • Experience coordinating with European sites, CROs, vendors, regulatory authorities, and ethics committees • Cardiovascular and catheter-based medical device clinical study experience highly valued; other relevant medical device experience also considered • Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or a related scientific discipline • Experience leading study-level clinical operations, including study startup, vendor management, enrollment forecasting, study metrics, and cross-functional execution • Experience managing clinical trial timelines, budgets, operational deliverables, and external vendors • Experience overseeing clinical studies from startup through closeout • Strong working knowledge of FDA regulations, ICH/GCP, ISO 14155, European Union regulatory and ethics committee requirements, and clinical research operations • Knowledge of applicable ISO standards, EU MDR 2017/745, GCP, and medical device clinical research regulatory requirements • Ability to collaborate across US and European time zones • Ability and willingness to travel internationally up to 30% • Permanently authorized to work in the United States without current or future visa sponsorship • Adaptability, initiative, collaboration, leadership, communication, organizational, and problem-solving skills

🏖️ Benefícios

• Bonus opportunities • Equity • Company-sponsored benefits • Opportunity to help bring a first-of-its-kind therapy to patients with coronary microvascular dysfunction • Work alongside an experienced leadership team • Visible impact in a collaborative, fast-moving environment