Massachusetts Licensed Clinical Study Manager

Job Summary

A company is looking for a Clinical Study Manager.

Key Responsibilities

• Oversee planning, execution, and closure of clinical trials to ensure compliance with protocols and regulations
• Lead daily operations of clinical studies, managing risks and issues that arise during trials
• Coordinate cross-functional teams and regulatory documentation for clinical studies

Required Qualifications

• Bachelor's degree in life sciences or a related field (advanced degree preferred)
• 3-5 years of research experience, with at least 2 years in a study management role
• Knowledge of ICH-GCP, FDA, EMA, and relevant regulatory guidelines
• Familiarity with clinical trial management systems and related tools
• Strong organizational and project management skills