Associate Director Of Clinical Operations

Overview

• Lead clinical trial management strategies and oversee global execution of complex trials.
• Collaborate with internal and external stakeholders to ensure compliance with regulations and company SOPs.
• Champion quality and continuous process improvement throughout clinical trial lifecycles.
• Develop operational plans aligning with study and organizational objectives.
• Manage vendor relationships, ensuring adherence to contracted scopes of work.
• Provide operational input for risk assessments and protocol development processes.
• Ensure inspection readiness and maintain integrity of trial master files.
• Coordinate responses to regulatory and ethical review board inquiries.

Key Responsibilities & Duties

• Oversee day-to-day operations of assigned clinical studies to meet program goals.
• Lead cross-functional teams and ensure vendor compliance with project scopes.
• Establish and manage clinical trial budgets, tracking financial status against approved plans.
• Develop operational plans for patient recruitment, site monitoring, and clinical supply management.
• Perform vendor management, including scope negotiations and performance oversight.
• Ensure documentation sufficiency for sponsor oversight and regulatory compliance.
• Prepare and manage study initiation and execution materials and presentations.
• Monitor clinical trial data currency and ensure milestone achievement.

Job Requirements

• Bachelor's degree in life sciences; advanced degree preferred.
• Minimum of 6 years of clinical trial management experience, preferably in biotech.
• Strong knowledge of ICH/GCP/FDA regulations and site monitoring practices.
• Proven ability to manage complex clinical study designs and operational aspects.
• Experience with global environments and vendor/CRO management.
• Excellent communication, analytical, and problem-solving skills.
• Attention to detail and ability to ensure inspection readiness.
• Willingness to travel domestically and internationally as needed.