Massachusetts Licensed GCP Manager

Job Summary

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

Key Responsibilities

• Project manage cross-functional study teams for GCP inspection readiness and activities
• Provide oversight and expert guidance on inspection readiness plans and TMF quality
• Collaborate with teams to monitor compliance and manage inspection readiness strategies

Required Qualifications

• Minimum of 6+ years of clinical research experience in the pharmaceutical or biotechnology field
• Solid knowledge of regulatory inspection readiness and execution processes
• Experience with CROs and outsourced clinical trial activities
• Bachelor's degree preferred or commensurate with experience
• Proficient in Microsoft Office for project management and presentations