Clinical Operations Associate Director

Job Summary

A company is looking for a Senior Manager/Associate Director, Clinical Operations.

Key Responsibilities

• Lead operational aspects and strategic input for clinical trials from planning to execution
• Oversee vendor activities, including selection, budget negotiation, and performance management
• Manage study timelines, budgets, and ensure compliance with regulatory guidelines

Required Qualifications

• BA/BS degree
• 7 or more years of clinical research experience in a biotech/pharmaceutical company or CRO
• Experience in developing study protocols and related documents
• Proven ability to lead outsourced studies and manage vendor operations
• Knowledge of FDA regulations and ICH/GCP guidelines