Senior Clinical Trials Manager – European Medical Device Studies

This is a fully remote position, open to applicants in New York.

📋 Description

• Oversee the operational planning and execution of multi-country European clinical trials for medical devices, from initiation through to study conclusion.

• Formulate and implement the startup strategy for studies, ensuring accountability for site activation across various European locations.

• Create and uphold study timelines, milestones, and operational outcomes.

• Lead the forecasting of enrollment, track study metrics, and generate operational reports.

• Recognize operational risks and devise mitigation strategies.

• Guarantee that execution conforms to protocols, timelines, budgets, business goals, European regulatory and ethical standards, and study plans.

• Act as the primary operational liaison for CROs, vendors, consultants, and external study collaborators.

• Manage vendor outcomes, timelines, communications, budgets, and performance quality.

• Maintain oversight of study-level contracts, site budgets, CROs, and vendors.

• Coordinate operational tasks among US and European vendors, sites, and stakeholders.

• Supervise study documentation, TMF quality assurance, and readiness for inspections.

• Ensure adherence to SOPs, GCP, FDA regulations, ISO 14155, EU MDR 2017/745, and quality-system standards.

• Lead the identification of risks, escalation of issues, and planning for mitigation.

• Oversee the follow-up and resolution of CAPA.

• Address and resolve operational challenges at the study level.

• Collaborate with Clinical Affairs, Regulatory, Quality, Engineering, and other internal teams.

• Conduct study team meetings and operational reviews across US and European time zones.

• Provide leadership with updates on studies, operational insights, enrollment predictions, and risk evaluations.

• Foster alignment among internal teams, vendors, and clinical sites.

• Ensure uniform execution of study processes across all participating European countries and sites.

⛳️ Requirements

• A minimum of 7 years of experience in managing clinical studies for medical devices, including clinical trial management on the sponsor side at an early-stage medical device startup.

• Required experience on the sponsor side; solely having CRO-based experience does not fulfill this criterion.

• Proven experience in managing clinical studies for medical devices across multiple European countries.

• Familiarity with coordinating efforts involving European sites, CROs, vendors, regulatory bodies, and ethics committees.

• Experience in cardiovascular and catheter-based medical device clinical studies is highly regarded; other relevant medical device backgrounds will also be considered.

• Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or a similar scientific field.

• Demonstrated experience in leading study-level clinical operations, encompassing study startup, vendor management, enrollment forecasting, study metrics, and cross-functional execution.

• Experience in managing clinical trial timelines, budgets, operational outputs, and external vendors.

• Proven ability to oversee clinical studies from inception to closure.

• Strong understanding of FDA regulations, ICH/GCP, ISO 14155, European Union regulatory and ethics committee requirements, and clinical research operations.

• Knowledge of relevant ISO standards, EU MDR 2017/745, GCP, and medical device clinical research regulatory requirements.

• Ability to collaborate effectively across US and European time zones.

• Willingness and ability to travel internationally up to 30% of the time.

• Must be permanently authorized to work in the United States without the need for current or future visa sponsorship.

• Possess adaptability, initiative, collaboration, leadership, communication, organizational, and problem-solving skills.

🏝️ Benefits

• Opportunities for bonuses.

• Equity participation.

• Company-sponsored benefits.

• Opportunity to contribute to the introduction of a pioneering therapy for patients with coronary microvascular dysfunction.

• Collaborate with an experienced leadership team.

• Make a visible impact in a fast-paced, collaborative environment.