Clinical Quality Compliance Lead

Job Summary

A company is looking for a Clinical Quality Compliance Lead to provide guidance on inspection readiness and compliance in clinical trials.

Key Responsibilities

• Provide just-in-time guidance to study teams on operating model processes and documentation for inspection readiness
• Manage inspection readiness planning and oversee TMF performance and compliance processes
• Facilitate study team preparedness for audits and inspections, ensuring effective communication and issue escalation

Required Qualifications

• Minimum of 6+ years of clinical research experience in the pharmaceutical or biotechnology field
• Solid knowledge of GCP compliance and regulatory inspection readiness
• Experience with CROs and outsourced clinical trial activities
• Bachelor's degree preferred or equivalent experience
• Proven project management skills and ability to work in a fast-paced environment