Clinical Quality Lead

Job Summary

A company is looking for a Clinical Quality Lead responsible for ensuring high-quality standards in global clinical trials.

Key Responsibilities

• Serve as the primary Quality point of contact for assigned clinical trials
• Lead GCP quality oversight and manage clinical trial audit programs
• Drive investigation of trial quality events and oversee vendor performance

Required Qualifications, Training, and Education

• MS Degree
• Minimum 7 years of clinical trial experience
• Minimum 5 years of quality assurance experience
• Experience with FDA, EMA, MHRA, PDMA inspections
• In-depth knowledge of US and EU regulations and ICH GCP Guidelines