Clinical Document Management Specialist

Job Summary

A company is looking for a SMA I.

Key Responsibilities

• Receive and log study documentation into an internal tracking system
• Set up and maintain the Trial Master File (TMF) according to client specifications and standards
• Prepare the TMF for audits and manage quality control findings

Required Qualifications

• Undergraduate degree in a clinical, science, or related field
• Prior experience in records management or office support
• Experience using computerized information systems
• Industry experience with accountability to vendors or clients
• Knowledge of ICH/GCP and local regulatory authority regulations