Clinical Quality Compliance Lead

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

May 24, 2025 - 02:40

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