eTMF Specialist

Job Summary

A company is looking for an eTMF Specialist to join their eTMF team.

Key Responsibilities

• Lead and manage eTMF activities, acting as the primary contact for project teams and vendors
• Author quality review documentation and study-specific eTMF Management Plans
• Perform quality checks, oversee document transfers, and provide ongoing training to team members

Required Qualifications

• Bachelor's degree in information management, library science, clinical science, or a related field
• 2-4 years of clinical trial records management experience in the pharmaceutical or biotech industry
• Experience with computerized clinical trials records management technologies
• Global clinical trials experience is preferred
• Knowledge of web-based communication tools and IT systems is preferred