Local Study Associate Director

Title: Local Study Associate Director Location: Field At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week . Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.    Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.    Introduction to the Role: The Local Study Associate Director (LSAD) leads Local Study Teams at the country level to deliver assigned components of clinical studies according to agreed resources, budgets, and timelines. The LSAD ensures compliance with AstraZeneca procedural documents, international guidelines such as ICH-GCP, and applicable local regulations. In addition to leading Local Study Teams, the LSAD may perform site monitoring activities as needed to support AstraZeneca’s flexible capacity model. The role is responsible for ensuring that sites are identified, qualified, initiated, monitored, closed, and appropriately documented and archived. Depending on experience, performance, level of independence, and ability to take on additional responsibilities or mentor junior colleagues, LSADs may be assigned different internal titles, including Local Study Associate Director or Senior Local Study Associate Director . The applicable internal title may be assigned by the Director or Country Head, following confirmation with the appropriate Senior Director, Cluster Head, Executive Director, or Regional Head. Key Accountabilities • Has overall responsibility for country-level study commitments and the timely delivery of high-quality data. • Leads the Local Study Team, including Clinical Research Associates and Clinical Study Associates, for assigned studies. • Leads and optimizes Local Study Team performance at the country level, ensuring compliance with AstraZeneca procedural documents, ICH-GCP, and applicable local regulations. • Ensures that clinical and operational feasibility assessments for potential studies are completed to the highest quality. • Coordinates site selection activities, including identifying potential sites and investigators, completing initial Site Quality Risk Assessments, and conducting Site Qualification Visits. • Ensures the timely submission of applications and required documents to Ethics Committees and Institutional Review Boards during study start-up and throughout the study. • Partners with Regulatory Affairs to ensure timely submissions to Regulatory Authorities in accordance with applicable local regulations. • Ensures the timely preparation of country financial Study Management Agreements and maintains accurate study budgets in AstraZeneca’s clinical study financial systems. • Conducts regular reviews of financial systems and reports in alignment with the Director of Study Management and Monitoring or Country Head. • Ensures the timely preparation and maintenance of local Master Clinical Study Agreeme