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

Eligibility

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.

Location and Compensation

This is a US-based remote position supporting clinical studies and sites across the European Union. Candidates living on the East Coast within reasonable proximity to a major international airport will be prioritized. The role requires regular collaboration across US and European time zones and international travel of up to 30% based on study and business needs.

The anticipated annual base salary range for this position is $158,000-$214,000, based on New York metropolitan area salary data. Actual compensation will be determined based on experience, qualifications, geographic location, and other job-related factors. VahatiCor is committed to fair and equitable pay practices. In addition to base salary, the total compensation package may include bonus opportunities, equity, and company-sponsored benefits.

Why Work at VahatiCor?
• Help bring a first-of-its-kind therapy to patients with coronary microvascular dysfunction, a large and historically underserved patient population with limited treatment options.
• Work alongside an experienced leadership team with deep expertise in cardiovascular medical devices, clinical research, regulatory affairs, and commercialization.
• Make a visible impact in a collaborative, fast-moving environment where individual contributions directly influence the future of the technology, the clinical program, and the company.

Equal Opportunity Statement

VahatiCor is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are based on qualifications, merit, and business needs. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.

Third-Party Recruiter Notice

We do not accept unsolicited resumes from staffing agencies or recruiters without a signed agreement in place. Any resumes submitted without such an agreement will be considered the property of VahatiCor and no fees will be paid if the candidate is hired. Agencies interested in submitting candidates may email [click to reveal email address] View email address on us.fitly.work .