Senior Associate Study Manager

Job Summary

A company is looking for a Senior Associate Study Manager.

Key Responsibilities

• Support the execution and monitoring of clinical studies and trial deliverables
• Participate in study planning, vendor management, and coordination of study implementation plans
• Assist in preparing and managing study budgets, timelines, and site start-up activities

Required Qualifications and Education

• Knowledge of ICH, GCP, FDA regulations, and international regulatory standards
• Experience with external vendors, including CROs and contract labs
• Proficient in project planning and oversight of study deliverables
• Master's degree, or Bachelor's/RN with 3+ years of experience, or Associate's with 6+ years, or High School diploma with 10+ years in a related field
• Well-versed in the drug development process and related procedures