Clinical Team Manager (CTM) - FSP

Clinical Team Manager position overseeing operational and quality aspects of low to moderate complexity clinical trials at a contract research organization. Responsible for delivering study objectives on time and within budget while maintaining regulatory compliance and team coordination.

Responsibilities

• Manage clinical operations and quality of assigned studies within protocol and regulatory requirements
• Develop monitoring plans, trial master files, and clinical documentation tools
• Lead clinical team coordination and conduct regular team meetings to track timelines and deliverables
• Monitor study performance against contractual timelines and metrics; implement corrective actions as needed
• Communicate with study sites regarding protocol compliance, enrollment, and case report form issues

Requirements

• Bachelor's degree or equivalent formal qualification
• 5+ years of experience in clinical operations or related field
• Strong knowledge of ICH/GCP guidelines and FDA regulations
• Demonstrated leadership and team mentoring capabilities
• Proficiency in project management tools, Excel, and clinical databases
• Excellent written and verbal communication skills in English