Associate Director, Regional Clinical Study Management

Role: Regional Study Manager responsible for overseeing clinical study delivery within a specified region, ensuring quality, adherence to timelines and budgets, and inspection readiness. Objectives include leading regional clinical operations teams, managing external vendors, and collaborating with stakeholders to achieve study milestones. Responsibilities encompass study planning from feasibility through closeout, developing regional tools and SOPs, managing trial site selection, regulatory submissions, and data collection, and ensuring compliance with GxP and ICH/GCP standards. The role also involves budget management, resource allocation, and mentoring junior team members. Requirements: Bachelor's in a scientific or healthcare discipline with 8+ years of clinical operations experience in biotech, pharma, or CRO settings; master’s degree preferred with 6+ years' experience. Skills include strong leadership, communication, judgment, and multitasking abilities; proficiency in MS Office and project planning tools. High-value specifics: Experience in late-stage clinical trials (Phases 2-3), cross-functional stakeholder engagement, vendor management, and regulatory compliance. Travel may be required based on business needs. The position reports to senior management and involves leading efforts across clinical operations, quality, and study management functions.