This role is based in Barcelona, with an on-site commitment of three days a week. Fluency in English is required.
Are you ready to lead the charge in clinical studies at the country level? As a Local Study Associate Director, you'll spearhead Local Study Teams (LSTs) to deliver critical components of clinical studies, ensuring compliance with AZ Procedural Documents, international guidelines like ICH-GCP, and local regulations. In addition to leading LSTs, you may also perform site monitoring to support our flexible capacity model. Your role will be pivotal in identifying sites, performing qualifications, and ensuring seamless study execution from initiation to closure. Are you up for the challenge?
• Take full responsibility for study commitments within the country and ensure timely delivery of high-quality data.
• Lead Local Study Teams consisting of CRAs and CSAs for assigned studies.
• Optimize team performance at the country level, ensuring compliance with AZ Procedural Documents, ICH-GCP, and local regulations.
• Conduct clinical and operational feasibility assessments of potential studies with precision.
• Coordinate site selection by identifying potential sites/investigators and conducting Site Qualification Visits.
• Ensure timely submission of applications/documents to EC/IRB and Regulatory Authority throughout the study.
• Prepare and maintain accurate study budgets and agreements in AZ clinical studies financial system.
• Develop country-level Master Informed Consent Forms and ensure compliance with AZ SOPs and local regulations.
• Collect and verify trial essential documents prior to study start, ensuring sites are ready to enroll.
• Plan and coordinate local drug activities, from purchase to destruction.
• Manage monitoring activities from site activation to study closure in accordance with Monitoring Plans.
• Review monitoring visit reports and advise monitors on study-related matters.
• Identify risks and resolve complex study problems proactively.
• Organize regular Local Study Team meetings with a focus on collaboration.
• Report study progress to the Global Study Associate Director/Global Study Team.
• Contribute to patient recruitment strategy and communicate regularly with Investigators.
• Develop risk management plans at the country study level and manage stakeholders effectively.
• Lead National Investigator meetings as required.
• Forecast study timelines, resources, recruitment, budget, materials, and drug supplies.
• Ensure systems for business-critical activities are set up and updated at the country level.
• Ensure accurate payments related to the study are performed according to regulations.
• Train and coach new Local Study Team members in compliance with ICH-GCP and AZ Procedural Documents.
• Maintain eTMF "Inspection Ready" status by uploading essential documents timely.
• Lead activities associated with audits and regulatory inspections in liaison with CQAD and QA.
• Provide input for process development and improvement.
• Update Line Managers on study milestones/key issues and CRA/CSA performance.
• Ensure compliance with AstraZeneca’s Code of Ethics, policies, and procedures.
• Bachelor’s degree in relevant discipline.
• Significant experience in Study Management within a pharmaceutical or clinical background.
• Thorough knowledge of Patient Safety processes and local regulations.
• Advanced degree within field.
• Professional certification.
• Clinical study delivery operational experience.
• Project management experience.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca, we are driven by a vision to eliminate cancer as a cause of death. Our team is dedicated to pioneering new frontiers in Oncology, fusing cutting-edge science with the latest technology to achieve breakthroughs. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we are empowered to lead at every level. We make bold decisions driven by patient outcomes, collaborating seamlessly with academia and industry to expedite research in some of the hardest-to-treat cancers. Join us in making a meaningful impact on millions of lives.
Ready to take the next step in your career? Apply now and become part of our dynamic team!
Date Posted
06-nov-2025Closing Date
19-nov-2025AstraZeneca 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.