LSAD (Local Study Associate Director)

Job Title: LSAD (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.   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 Role: The Local Study Associate Director (LSAD) is responsible for managing their assigned clinical studies and leading Local Study Teams (LSTs) to ensure delivery of country-level study commitments according to agreed budgets, timelines and resources assigned by Director Country Head (DCH) or Director Site Management & Monitoring (DSMM). All activities must comply with AstraZeneca Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. This role reports to DCH or DSMM, depending on country-specific organisational set-up and works in alignment with Global Study Team (GST), for delivery of assigned studies. Beyond leadership of LSTs, the LSAD may also engage in site monitoring activities as required, supporting the flexible capacity model. The LSAD ensures that study sites are appropriately identified, qualify for participation, are set-up, initiated, and monitored throughout the study, and that closure and archiving of site documentation are completed according to standards. Accountabilities: Hold overall responsibility for fulfilling country-level study commitments and ensuring timely, high-quality data delivery. • Lead the Local Study Team(s), comprising Clinical Research Associates (CRAs), Clinical Study Administrators (CSAs), and other contributors, for assigned studies, fostering collaboration and high performance. • Drive optimal performance and compliance of Local Study Team(s) with AstraZeneca Procedural Documents, ICH-GCP requirements, and local regulations. • Ensure the highest quality in the clinical and operational feasibility assessment of potential studies, as required. • Coordinate and oversee the site selection process, identifying potential sites and investigators, conducting initial site quality risk assessments, and, when necessary, performing Site Qualification Visits to evaluate suitability and quality risk. • Ensure timely submission of required applications and documentation to Ethics Committees/Institutional Review Boards (IRBs) and, in partnership with Regulatory Affairs, support the delivery of study submissions to Regulatory Authorities in line with local regulations. • Prepare accurate country-level financial agreements and maintain up-to-date study budgets within the clinical financial system, ensuring regular checks and alignment with input from the Director, SMM or Director, Country Head, and Clinical Finance reporting function, as appropriate. • Ensure the setup and ongoing management of studies within CTMS, the electronic Trial Master File (eTMF), study finance systems, and any other tools or local platforms necessary to meet country-specific laws and requirements. • Oversee, manage, and coordinate all monitoring activities from site activation to closure in