Senior Manager, GCP Excellence

Job Summary

A company is looking for a Senior Manager, GCP Excellence in Clinical Trials.

Key Responsibilities

• Project manage and facilitate GCP inspection readiness and activities for cross-functional study execution teams
• Provide expert GCP guidance and oversight to ensure compliance and adherence to inspection readiness strategies
• Coordinate TMF processes and manage inspection readiness strategies in collaboration with study execution teams

Required Qualifications

• Bachelor's degree preferred or equivalent experience
• 6 or more years of clinical research experience in the pharmaceutical or biotechnology field
• Knowledge of regulatory inspection readiness and execution processes
• Experience with CROs and outsourced clinical trial activities
• Solid understanding of drug development and clinical trial processes