Senior Clinical Trials Manager

This is a fully remote position, open to applicants in California.

📋 Description

• Lead the operational planning and execution of clinical studies from initiation to study closeout.

• Take ownership of the study startup strategy and ensure accountability for site activation progress across all involved sites.

• Develop and uphold study timelines, milestones, and operational deliverables.

• Oversee enrollment forecasting, study metrics, and operational reporting.

• Identify operational risks and implement mitigation strategies to sustain study performance.

• Ensure that study execution aligns with protocol requirements, timelines, budgets, and business objectives.

• Act as the primary operational liaison for CROs, vendors, consultants, and external study partners.

• Manage vendor deliverables, timelines, communication, budgets, and performance metrics.

• Maintain study-level vendor oversight and operational responsibility.

• Collaborate with Clinical Affairs and study leadership to oversee site budgets and contracts.

• Ensure that operational activities are aligned across vendors, sites, and internal stakeholders.

• Maintain oversight of study documentation, TMF quality, and readiness for inspections.

• Ensure compliance of study conduct with SOPs, GCP, FDA regulations, quality system requirements, and study plans.

• Take ownership of study-level risk identification, issue escalation, and mitigation planning.

• Oversee CAPA follow-up and resolution activities.

• Drive the resolution of operational challenges at the study level.

• Collaborate closely with Clinical Affairs, Regulatory, Quality, Data Management, Engineering, and other internal stakeholders.

• Lead study team meetings and operational reviews.

• Provide regular updates on study status, operational insights, enrollment forecasts, and risk assessments to leadership.

• Facilitate alignment across internal teams, vendors, and clinical sites.

• Ensure consistent execution of study processes across all participating sites.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or a related scientific field.

• 7+ years of experience in managing clinical studies within the medical device sector.

• Strong preference for experience with cardiovascular and catheter-based medical device clinical studies.

• Proven experience in leading study-level clinical operations activities, including study startup, vendor management, enrollment forecasting, study metrics, and cross-functional execution.

• Demonstrated ability to manage clinical trial timelines, budgets, operational deliverables, and relationships with external vendors.

• Proven track record in overseeing clinical studies from startup through to closeout.

• Comprehensive understanding of FDA regulations, ICH/GCP guidelines, and clinical research operations.

• Exceptional leadership, communication, organizational, and problem-solving abilities.

• Willingness and ability to travel up to 30% based on study and business needs.

🏝️ Benefits

• Bonus opportunities

• Equity

• Company-sponsored benefits