Clinical Trials Manager

Overview

In this role you will lead and coordinate operational activities for assigned clinical studies, both domestically and globally. You will manage CROs and CSPs, ensuring studies comply with FDA, EU, ICH, and SOPs, while partnering with cross-functional teams. You’ll contribute to study design discussions, timelines, and monitoring plans to meet corporate goals. You will drive enrollment strategies and oversee both CRO-backed and in-house studies to maintain quality and timelines. This is an opportunity to shape clinical execution in a mission‑driven neuroscience-focused company.

Responsibilities

• Ensure studies comply with FDA, EU, ICH, and SOPs/policies
• Serve as primary operations contact for assigned studies
• Contribute to study design discussions and study reports
• Manage CROs/CSPs and monitor vendor performance
• Lead study team meetings and manage timelines
• Identify enrollment barriers and develop recruitment solutions
• Oversee internally run studies including CRAs and monitoring plans
• Collaborate to enforce standard processes across programs
• Perform other duties as assigned

Key requirements

• BS/BA degree with 6+ years of clinical trial management experience (domestic and international) or Master’s with 4+ years of experience
• Detailed knowledge of clinical drug development, ICH, GCP, FDA regulations, and EU Directive
• Strong clinical operations knowledge from start-up to close-out
• Broad trial management and process knowledge
• Ability to organize resources, set objectives, and provide direction
• Leadership experience and ability to manage multiple teams
• Excellent computer, communication, problem-solving, and analytical skills
• Ability to meet multiple deadlines with high accuracy and efficiency
• Experience partnering cross-functionally and with customers to drive results
• Experience monitoring budgets and CRO/vendor management

• strong communication
• problem-solving
• analytical thinking
• clinical trial management
• CRO/vendor management
• monitoring plans and on-site monitoring

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