Senior Clinical Trials Manager - European Medical Device Studies

T45 Labs•New York, NY

12d•Remote

About The Position

VahatiCor is a medical device company developing breakthrough cardiovascular technologies, including Class III catheter-based systems. We operate with a purpose-driven, agile, and collaborative culture, where each team member plays a meaningful role in advancing solutions that improve patient outcomes. As our clinical program expands, we are building a strong clinical operations function to support early feasibility studies and future pivotal trials. The Senior Clinical Trials Manager will lead the planning, execution, and operational oversight of multi-country medical device clinical trials across the European Union from startup through study closeout. Based remotely in the United States, this role is accountable for study timelines, budgets, vendor performance, enrollment forecasting, study metrics, risk management, and cross-functional execution. The ideal candidate brings sponsor-side clinical trial management experience working for early-stage medical device companies and experience managing European clinical studies. Cardiovascular and catheter-based medical device experience is highly valued.

Requirements

7+ years of experience managing medical device clinical studies, including sponsor-side clinical trial management experience working for an early-stage medical device startup company.
Sponsor-side experience is required; candidates whose experience is exclusively within CROs will not meet this requirement.
Experience managing multi-country European medical device clinical studies, including coordination with European sites, CROs, vendors, regulatory authorities, and ethics committees, is required.
Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or a related scientific discipline.
Experience leading study-level clinical operations activities, 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 study closeout.
Strong working knowledge of FDA regulations, ICH/GCP, ISO 14155, applicable 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.
Strong leadership, communication, organizational, and problem-solving skills.
Ability to collaborate effectively across US and European time zones.
Ability and willingness to travel internationally up to 30% based on study and business needs.
Thrives in a dynamic, fast-paced, early-stage medical device environment where adaptability, initiative, and collaboration are critical to success.
Candidates must be permanently authorized to work in the United States without the need for current or future visa sponsorship.
We are currently unable to sponsor employment visas or permanent residency (PERM) applications.

Nice To Haves

Cardiovascular and catheter-based medical device clinical study experience is highly valued; candidates with other relevant medical device experience will also be considered.

Responsibilities

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 progress across participating 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 to maintain study performance.
Ensure study execution remains aligned with protocol requirements, timelines, budgets, business objectives, and applicable European regulatory and ethics committee requirements.
Serve as the primary operational contact for CROs, vendors, consultants, and external study partners supporting European clinical studies.
Manage vendor deliverables, timelines, communication, budgets, and performance.
Maintain study-level oversight of CROs and external vendors while representing the sponsor’s operational priorities.
Maintain oversight of site budgets and contracts in collaboration with Clinical Affairs and study leadership.
Ensure operational activities remain aligned across vendors, sites, and internal stakeholders in the US and Europe.
Maintain oversight of study documentation, TMF quality, and inspection readiness activities.
Ensure study conduct remains compliant with SOPs, GCP, FDA regulations, ISO 14155, EU MDR 2017/745, and other applicable European Union regulatory and ethics committee requirements, quality system requirements, and study plans.
Lead study-level risk identification, issue escalation, and mitigation planning.
Maintain oversight of CAPA follow-up and resolution activities.
Drive resolution of study-level operational challenges.
Partner closely with Clinical Affairs, Regulatory, Quality, Engineering, and other internal stakeholders.
Lead study team meetings and operational reviews across US and European time zones.
Provide regular study updates, operational insights, enrollment forecasts, and risk assessments to leadership.
Drive alignment across internal teams, vendors, and clinical sites.
Ensure consistent execution of study processes across participating European countries and sites.