Clinical Team Manager/Sr. (CTM) - FSP

Clinical Team Manager responsible for delivering final clinical study data on time and within budget at Thermo Fisher Scientific's PPD division. The role involves managing monitoring operations, ensuring regulatory compliance, coordinating with study sites, and leading cross-functional teams on moderate to high-complexity trials.

Responsibilities

• Manage monitoring operations and quality for assigned studies with ICH GCP compliance
• Develop clinical tools and study plans; collaborate with sponsor CSO and lead team meetings
• Ensure timely study deliverables, coordinate site activities, and address regulatory requirements
• Identify and report site performance issues, conduct trend analysis, and escalate problems
• Conduct site visits with site managers and communicate study progress to sponsors

Requirements

• Bachelor's degree with 5+ years monitoring or study management experience
• Advanced mentoring, leadership, and supervisory skills
• Extensive clinical trials monitoring expertise, both remote and onsite
• Strong knowledge of ICH GCP, FDA guidelines, and relevant regulatory frameworks
• Excellent organizational, communication, and problem-solving abilities
• Neuroscience experience preferred
• Prior client-dedicated clinical research experience preferred