Senior Clinical Trial Manager

Senior Clinical Trial Manager

The Senior Clinical Trial Manager provides strategic and operational leadership for global clinical programs, with a focus on renal denervation (RDN) and cardiology clinical trials. This role leads Clinical Trial Managers and study teams to ensure successful planning, execution, and delivery of clinical studies in alignment with program strategy, timelines, budget, quality standards, and regulatory requirements.

This position plays a critical role in driving clinical excellence, managing vendor performance, and ensuring inspection readiness across the full lifecycle of clinical trials.

Key Responsibilities

• Lead, mentor, and develop Clinical Trial Managers and study personnel, fostering a high-performing and collaborative team environment
• Oversee end-to-end execution of global clinical trials, ensuring compliance with protocols, GCP, SOPs, and regulatory requirements
• Translate program strategy into operational plans, timelines, and resource allocations
• Ensure cross-functional alignment and timely achievement of study milestones
• Oversee development and maintenance of study documentation, including operational plans, study materials, and regulatory submissions
• Manage CROs and external vendors, including selection, contracting, performance oversight, and issue escalation
• Monitor and manage clinical trial budgets, including forecasting, accruals, and variance analysis
• Identify risks proactively and implement mitigation and contingency plans
• Provide clear, data-driven updates, risk assessments, and recommendations to leadership and governance teams
• Build and maintain strong relationships with investigators, clinical sites, and key opinion leaders to support enrollment and engagement
• Ensure inspection readiness and compliance with internal quality standards and regulatory expectations
• Drive continuous improvement in clinical operations processes, tools, and best practices

Required Qualifications

• Bachelor's degree in a scientific or healthcare-related field (advanced degree preferred)
• Minimum 10+ years of clinical research experience, including global clinical trials and vendor management
• 5+ years of leadership experience managing clinical trial teams (preferred)
• Strong knowledge of GCP, ICH guidelines, and global regulatory requirements
• Proven experience managing complex timelines, budgets, and cross-functional initiatives
• Demonstrated experience supporting internal and regulatory audits
• Excellent communication, negotiation, and stakeholder management skills
• Ability to operate effectively in a fast-paced, matrixed environment managing multiple studies and direct reports

Preferred Experience

• Renal Denervation (RDN) clinical trials
• Cardiology clinical trials
• Clinical trial people management and team leadership