Global Study Associate Director

Global Study Associate Director leading end-to-end delivery of complex clinical trials at AstraZeneca in Durham, NC. The role encompasses cross-functional team leadership, vendor management, regulatory compliance, and operational oversight to ensure studies meet quality, timeline, and budget standards.

Responsibilities

• Lead cross-functional study teams and vendor partners to achieve timelines, budgets, and quality standards
• Orchestrate communication across functions and conduct investigator meetings to maintain alignment
• Build and maintain risk-based quality plans with proactive escalation and contingency strategies
• Oversee vendor performance including CROs and central labs; document oversight and manage issues
• Monitor operational KPIs, manage study budgets, and ensure inspection readiness with robust documentation

Requirements

• Bachelor's degree in medical, biological sciences, or clinical research-related field
• 5+ years pharmaceutical industry clinical experience including 2+ years project management
• Extensive ICH-GCP and clinical regulatory requirements knowledge
• Demonstrated project management skills and tool proficiency
• Strong team leadership and stakeholder relationship management abilities
• Excellent communication, strategic thinking, and problem-solving skills
• Ability to manage multiple competing priorities effectively