Sr. Clinical Trials Manager - VahatiCor

Sr. Clinical Trials Manager – VahatiCor
Status: Full-time, Exempt
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 Sr. Clinical Trials Manager will lead the planning, execution, and operational oversight of clinical studies from startup through study closeout. This role serves as the study-level operational owner, accountable for timelines, budgets, vendor performance, enrollment forecasting, study metrics, risk management, and cross-functional execution. The ideal candidate brings deep experience in clinical operations leadership, study management, and cardiovascular medical device studies.

Responsibilities

Study Planning & Execution

▪ Lead operational planning and execution of clinical studies from startup through study closeout.
▪ Own study startup strategy and maintain accountability for site activation progress across all participating sites.
▪ Develop and maintain study timelines, milestones, and operational deliverables.
▪ Own 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, and business objectives.

Vendor & Operational Management

▪ Serve as the primary operational contact for CROs, vendors, consultants, and external study partners.
▪ Manage vendor deliverables, timelines, communication, budgets, and performance.
▪ Own study-level vendor oversight and operational accountability.
▪ 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.

Documentation & Quality

▪ Maintain oversight of study documentation, TMF quality, and inspection readiness activities.
▪ Ensure study conduct remains compliant with SOPs, GCP, FDA regulations, quality system requirements, and study plans.
▪ Own 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, Data Management, Engineering, and other internal stakeholders.
▪ Lead study team meetings and operational reviews.
▪ 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 sites.

Required Experience & Qualifications

▪ Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or a related scientific discipline.
▪ 7+ years of experience managing clinical studies within the medical device industry.
▪ Experience with cardiovascular and catheter-based medical device clinical studies strongly preferred.
▪ Demonstrated experience leading study-level clinical operations activities, including study startup, vendor management, enrollment forecasting, study metrics, and cross-functional execution.
▪ Demonstrated experience managing clinical trial timelines, budgets, operational deliverables, and external vendors.
▪ Demonstrated experience overseeing clinical studies from startup through study closeout.
▪ Demonstrated understanding of FDA regulations, ICH/GCP, and clinical research operations.
▪ Strong leadership, communication, organizational, and problem-solving skills.
▪ Ability and willingness to travel 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