Manager Study Management - Biosimilars

Job Summary

A company is looking for a Manager Study Management - Biosimilars.

Key Responsibilities

• Lead and manage clinical trials from study design to closeout in collaboration with CROs
• Oversee operational execution and ensure compliance with ICH-GCP guidelines
• Communicate study status and manage program-level operational issues with senior management

Required Qualifications

• Bachelor's degree & 5 years, Master's degree & 3 years, or Doctorate degree & 2 years of related experience
• Experience with oversight of clinical research organizations (CROs)
• Experience in leading cross-functional teams
• 7-9 years of experience in life sciences or biopharmaceutical clinical research preferred
• Knowledge of Good Clinical Practices (GCP) and FDA regulations