Clinical Records Management Manager

Job Summary

A company is looking for a Manager, Clinical Records Management.

Key Responsibilities

• Conducts quality reviews of Trial Master Files for completeness and timeliness
• Provides central records support across various stakeholders, including study teams and vendors
• Drafts documents for clinical records management in compliance with GCP and regulations

Required Qualifications

• Bachelor's or advanced degree in life sciences, pharmacy, or a related field
• Minimum of 6-8 years of relevant experience in the biotech or pharmaceutical industry without a Master's, or 4-6 years with a Master's
• Experience in clinical records management and understanding of GCP and regulatory guidelines
• Familiarity with Trial Master File structure and TMF systems
• Experience working with vendors and supporting regulatory inspections