Senior Clinical Trial Manager
ShiftCode Analytics
Interview : Video
Visa : USC, GC
Position Overview
- 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
- 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
- Renal Denervation (RDN) clinical trials
- Cardiology clinical trials
- Clinical trial people management and team leadership
Vacancy posted 4 days ago
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