Local Study Associate Director

Job description

About AstraZeneca : AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that concentrates on the discovery, development and commercialization of prescription medicines addressing some of the planet’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. Introduction to role: Are you equipped to lead country-level clinical delivery that turns promising science into medicines for patients faster? In this role, you will be responsible for the delivery of assigned studies at country level, guiding Local Study Teams to hit breakthroughs on time, on budget and to the highest quality standards. Your leadership will translate strategy into action—accelerating recruitment, elevating data quality and ensuring inspection readiness—so decisions can be made with confidence. You will operate at the center of a high-performing matrix, aligning seamlessly with Global Study Teams while partnering with sites, investigators and local stakeholders. Do you thrive at the intersection of science, operations and people leadership, and enjoy solving complex study challenges with agility? You will also support an adaptable workload system, stepping into site monitoring where needed to unblock progress and keep delivery moving. Accountabilities: Country Study Delivery: Own end-to-end delivery of commitments for studies conducted within individual countries, ensuring timelines, budget and high-quality data. Leadership of the local site group: Guide CRAs, CSAs and other contributors to foster collaboration, accountability and high performance. Compliance Leadership: Ensure adherence to internal procedural guidelines, ICH-GCP and relevant local regulations at all times. Feasibility Excellence: Deliver robust clinical and operational feasibility assessments to inform study planning and site strategy. Site Strategy and Selection: Identify and assess potential sites and investigators, perform quality risk assessments and conduct Site Qualification Visits as needed. Ethics and Regulatory Submissions: Oversee EC/IRB submissions and partner with Regulatory Affairs on authority submissions in line with local requirements. Budgeting and Financial Stewardship: Prepare accurate country agreements, maintain up-to-date study budgets and align with clinical finance reporting. Systems and Tools Ownership: Set up and manage studies in CTMS, eTMF, finance systems and any required local platforms to meet country-specific requirements. Monitoring Oversight: Coordinate all monitoring activities from activation to closure; conduct detailed evaluations of monitoring visit reports and guide monitors. Carry out co-monitoring, accompanied visits and training together with CRAs to ensure quality and consistency. Risk Management and Escalation: Proactively identify risks, resolve complex issues swiftly and escalate appropriately. Team Rhythm and Communication: Organize and lead regular, agenda-driven Local Study Team meetings to drive clarity and momentum. Stakeholder Partnerships: Build strong relationships with site staff and global stakeholders to enable smooth delivery. Progress Reporting: Provide timely updates to the Global Study Associate Director, Global Study Team and SMM/Study Operations Lead as applicable. Recruitment Acceleration: Contribute to site-level recruitment strategies and maintain regular contact with investigators to meet enrolment goals. Country Risk Plan: Develop, maintain and review a study-level country risk management plan across sites, stakeholders, vendors and customers. National Leadership Interface: Coordinate closely with National Coordinating or National Lead Investigator on recruitment and study matters when applicable. Investigator Meetings: Plan and lead National Investigator Meetings in alignment with local codes. Forecasting and Planning: Assist forecasting for timelines, resource needs, recruitment, budgeting, materials and investigational product supply. Critical System Readiness: Ensure country-level set-up and access for Safety Reporting, Regulatory Submissions and Clinical Trial Transparency activities. Payment Accuracy: Ensure accurate, compliant study payments according to local regulations and agreements. Capability Building: Train and coach new Local Study Team members to uphold ICH-GCP and company standards. Inspection Readiness and Quality: Maintain an inspection-ready eTMF; plan and lead audit and regulatory inspection activities with Quality. Continuous Improvement: Contribute insights for process development and improvement, including feedback on research trends and competing studies. Leadership Visibility: Keep line managers regularly informed on study status, milestones, key issues and team performance. Cross-Functional Collaboration: Collaborate with Medical Affairs as needed and actively support study management and monitoring initiatives at local, regional or global levels. Flexible Capacity Support: Engage in site monitoring activities as required to support delivery. Essential Skills/Experience: Demonstrated ownership of country-level study delivery with on-time, on-budget, high-quality outcomes. Proven leadership of Local Study Teams of CRAs/CSAs and other contributors, fostering collaboration and high performance. Deep knowledge and application of ICH-GCP, local regulations and company procedural documents. Hands-on experience conducting clinical and operational feasibility assessments. Expertise in site strategy, including identification, initial quality risk assessment and conduct of Site Qualification Visits. Experience coordinating EC/IRB applications and documentation; partnership with Regulatory Affairs on authority submissions. <p