Job Summary: Lead the execution of global clinical studies in the country by directing local teams to meet timelines and regulatory requirements, and ensuring proper identification, qualification, initiation, and monitoring of study sites. Key Responsibilities: 1. Overall responsibility for clinical studies conducted in the country. 2. Leads local teams (CRA and CSA) for assigned studies. 3. End-to-end management of documentation and processes for regulatory approval. **Location** Buenos Aires, Buenos Aires F.D., Argentina **Job ID** R\-259147 **Date posted** 31/08/2026 ### **Job Purpose:** ### **Lead the in-country execution of global clinical studies. Lead country-level Local Study Teams (LST) to deliver committed clinical study components in accordance with agreed resources, budget, and timelines, while complying with AstraZeneca’s Standard Operating Procedures (SOPs), international guidelines such as ICH-GCP, and relevant local regulations. In addition to leading local study teams for assigned studies, the LSAD may conduct site monitoring as needed to support the flexible capability model. The LSAD is responsible for ensuring that sites are identified, appropriately qualified, set up, initiated, monitored, closed, and that documentation is archived.** ### **Key Responsibilities:** ### **• Has overall responsibility for clinical study commitments within the country. • Leads local teams (CRA(s) and CSA(s)) for the assigned study/studies. • Coordinates the site selection process by identifying potential sites/investigators, conducting initial assessments, and qualifying potential sites. • Manages or prepares documentation packages for ethics and regulatory submissions. Ensures timely submission of applications/documents to Ethics Committees and Regulatory Authorities. • Ensures preparation of the clinical study budget for the country and contracts with investigators. • Ensures collection of essential clinical study documents, importation of clinical study drug and materials, and setup of accounts for various clinical study vendors. • Sets up and maintains the Country-level Clinical Trial Management System (CTMS), coordinates monitoring activities, and reviews monitoring reports. • May conduct co-monitoring or CRA accompaniment/training visits. • Ensures the electronic Trial Master File (eTMF) remains complete and up-to-date. • Provides periodic updates to Country Line Directors on study progress, milestones, and team member performance.** ### **Requirements:** * **Completed university degree: Health-related fields such as Biology, Biochemistry, Pharmacy, Nutrition, Biotechnology, etc.** * **Minimum of 5 years’ experience in clinical research and local project management. Experience managing studies (projects) and serving as accountable for trial delivery.** * **Advanced English proficiency.** **Date Posted** 01\-sept\-2026 **Closing Date** 26\-sept\-2026 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry\-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non\-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Sofía González
Indeed · HR
Sofía González
Indeed · HR
