AstraZeneca - Wilmington, DE
posted 4 months ago
The Local Study Associate Director (LSAD) at AstraZeneca plays a pivotal role in leading Local Study Teams (LSTs) at the country level to ensure the successful delivery of clinical studies. This position is integral to the clinical development process, ensuring that studies are conducted in compliance with AstraZeneca's procedural documents, international guidelines such as ICH-GCP, and relevant local regulations. The LSAD is responsible for overseeing the entire lifecycle of clinical studies, from site identification and qualification to monitoring and closure, ensuring that all commitments are met within the agreed resources, budget, and timelines. In this remote position, the LSAD will lead a team of Clinical Research Associates (CRAs) and Clinical Study Associates (CSAs), optimizing their performance to ensure compliance and high-quality delivery of clinical trials. The LSAD will coordinate the site selection process, conducting thorough assessments of potential sites and investigators, and ensuring that all necessary documentation is submitted to ethics committees and regulatory authorities in a timely manner. This role also involves managing the financial aspects of the studies, including the preparation of study management agreements and maintaining accurate budgets. The LSAD will be proactive in identifying risks and resolving complex study-related issues, ensuring that monitoring activities are conducted according to the established plans. This position requires excellent project management skills, the ability to lead cross-functional teams, and a strong understanding of clinical trial operations. The LSAD will also be responsible for maintaining the study in the Clinical Trial Management System (CTMS) and ensuring compliance with local laws and regulations throughout the study lifecycle.