Senior Clinical Study Manager

Job Summary

A company is looking for a Senior Clinical Study Manager to oversee the execution of clinical studies and enhance study processes.

Key Responsibilities

• Oversee all phases of clinical studies, including site selection and close-out
• Manage study contracts and budgets while serving as the main contact for clinical sites
• Ensure compliance with regulatory standards and assist in regulatory submissions

Required Qualifications

• 6+ years of project management experience in medical device or drug development clinical trials, or 3-5+ years with an M.S. or PhD
• Familiarity with FDA/EMA regulations and GCPs/ICH guidelines
• Experience in digital pathology or imaging-based clinical trials is preferred
• Proficiency in data formatting and analysis using spreadsheets
• Strong organizational skills and curiosity