[Remote] Sr. Clinical Trials Manager - VahatiCor

Note: The job is a remote job and is open to candidates in USA. VahatiCor is a medical device company focused on developing innovative cardiovascular technologies. They are seeking a Sr. Clinical Trials Manager to lead the planning, execution, and oversight of clinical studies, ensuring alignment with timelines, budgets, and regulatory requirements.

Responsibilities

• 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
• 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
• 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
• 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

Skills

• 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
• 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
• Experience with cardiovascular and catheter-based medical device clinical studies strongly preferred

Benefits

• Bonus opportunities
• Equity
• Company-sponsored benefits

Company Overview