Clinical Study Manager

Job Summary

A company is looking for a Clinical Study Manager (CSM).

Key Responsibilities

• Manage clinical studies, ensuring compliance with GCP, ICH, and FDA regulations
• Oversee TMF management, site management, and CRO/vendor management
• Handle finance management, including budgets, contracts, and invoices

Required Qualifications

• University/college degree (BS/BA/MS) or certification in a related health profession
• 5-8 years of experience in clinical study management, with 2-3 years in a pharmaceutical setting
• Strong working knowledge of the clinical trial process
• Experience with cell/gene therapy and rare diseases is preferred
• Proficiency in computer skills, including MS Office and EDC systems