Senior Clinical Trial Manager

Job Summary

A company is looking for a Senior Clinical Trial Manager, Research Alliances.

Key Responsibilities

• Oversee the activation, execution, and management of Expanded Access Programs (EAPs) and Post Marketing studies
• Manage external contract research organizations and ensure compliance with regulatory requirements
• Report on study status and develop dashboards to communicate progress and risks

Required Qualifications, Training, and Education

• Bachelor's degree in a health or science-related area with 7+ years of clinical operations experience (or equivalent)
• Experience managing Expanded Access Programs and Phase 1-4 clinical trials
• Proven ability to build and maintain relationships with investigative sites
• Knowledge of US and Global Regulations and Guidance (ICH-GCP, FDA-CFR)
• Experience with data collection and monitoring of clinical studies