Local Study Associate Director

As a Study Country Lead at AstraZeneca, you will have the overall responsibility for the study commitments within the country and ensure timely delivery of data to the required quality. Leading the Local Study Team, you will work together with various stakeholders to optimize team performance and ensure compliance with AZ Procedural Documents, ICH-GCP, and local regulations. Your role will involve leading the site selection process, overseeing the submission of applications to EC/IRB and Regulatory Authority, preparing study budgets, and maintaining accurate financial records. You will be responsible for coordinating local drug activities, setting up and maintaining the study in CTMS, and managing monitoring activities from site activation through study closure. In addition, you will play a key role in identifying risks, resolving complex study problems, and proactively communicating study progress, risks, and mitigation plans to the Global Study Associate Director/ Global Study Team. Your contribution to patient recruitment strategy, risk management plan development, and participation in audits and regulatory inspections will be crucial to the success of the study. Collaboration with the local Medical Affairs team, ensuring compliance with AstraZeneca's Code of Ethics, and providing regular updates to Line Managers on study milestones are also significant aspects of this role. Your feedback on research-related information and compliance with local policies and code of ethics will further contribute to the success of the study. To excel in this role, you should have a Bachelor's degree in a relevant discipline, significant experience in Study Management within a pharmaceutical or clinical background, and thorough knowledge of Patient Safety processes and local regulations. Advanced degrees, professional certifications, clinical study delivery operational experience, and project management experience will be considered advantageous. Join us at AstraZeneca, where we are dedicated to being a Great Place to Work, empowering you to push the boundaries of science and unleash your entrepreneurial spirit. We are committed to building an inclusive and diverse team, welcoming applications from all qualified candidates, regardless of their characteristics. Embrace diversity, equality of opportunity, and join us on an exciting journey to pioneer the future of healthcare.,