Global Study Associate Director

Role: Lead global clinical study management, overseeing complex, cross-functional trials from start-up to close-out to ensure timely, quality, and compliant delivery. Responsibilities: manage study timelines, budgets, and vendor relations; coordinate communication among internal teams and external partners; maintain study documentation; oversee risk management, quality assurance, and inspection readiness; monitor KPIs, manage budgets, and ensure compliance with GxP, ICH-GCP, and regulatory standards; mentor team members and contribute to process improvements. Requirements: Bachelor's in medical or biological sciences; 5+ years in clinical research with at least 2 years in project management; extensive knowledge of clinical development processes, GCP, and regulatory requirements; strong leadership, communication, organizational, and conflict management skills. Preferred: advanced degree, project management certification, global project experience, familiarity with all phases of clinical trials. High-Value: clinical trials leadership in biopharma, with emphasis on study delivery, vendor oversight, compliance, and cross-functional collaboration; work in Durham, NC, with a hybrid work model.