Job Summary

• Serve as the liaison between Records Management and user departments regarding Trial Master Files (TMF), applying Records Management expertise to provide project related assistance across complex and multiple projects.
• Ensure all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, practices, good clinical practices, applicable regulatory requirements, and meets quality and timeline metrics.
• The role involves comprehensive TMF review including crosscheck and co-dependency checks to ensure inspection readiness of TMF.

Matching Summary

Skills & Requirements

Key Requirements

• High School Diploma or equivalent
• 3 years of Records Management experience
• Knowledge of ICH and GCP
• Ability to lead others

Work Rights