Senior Clinical Trials Manager - European Medical Device Studies

Title: Senior Clinical Trials Manager - European Medical Device Studies

Status: Exempt, Remote

Reports to: Sr. Clinical Program Manager
Overview

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.

Responsibilities

Study Planning and Execution

• 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.

Vendor and Operational Management

• 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.

Documentation and Quality

• 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.

Cross-Functional Collaboration

• 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.

Required Experience and Qualifications

• 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