LSAD (Local Study Associate Director)

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 accordance with Monitoring Plans, and thoroughly review monitoring visit reports, offering support and guidance to monitors.
• Conduct required co-monitoring visits, accompanied site visits, and training visits with study CRAs to ensure quality and consistency.
• Proactively identify risks, facilitate the swift resolution of complex study problems, and escalate as necessary.
• Organize and lead regular, agenda-driven Local Study Team meetings, fostering transparent communication and teamwork.
• Build and maintain positive relationships with Local Study Team members, site staff, and global stakeholders to ensure smooth study delivery.
• Report study progress and updates to the Global Study Associate Director, Global Study Team, and SMM/Study Operations Lead, as applicable.
• Contribute to patient recruitment strategies and maintain regular contact with investigators to support enrolment goals.
• Develop, maintain, and review a study-level country risk management plan, managing sites, stakeholders, vendors, and customers to ensure timely risk identification and mitigation.
• Coordinate closely with the National Coordinating Investigator or National Lead Investigator on recruitment and other study matters, when applicable.
• Plan and lead National Investigator Meetings in alignment with local codes, as needed.
• Assist with forecasting for study timelines, resource needs, recruitment, budgeting, materials, and investigational product supply.
• Ensure the setup, updating, and access to business-critical systems for activities such as Safety Reporting, Regulatory Submissions, and Clinical Trial Transparency at the country level.
• Ensure accuracy and compliance of all study payments, adhering to local regulations and agreements.
• Participate in the training and coaching of new Local Study Team members, ensuring quality and adherence to ICH-GCP standards and AstraZeneca procedures.
• Maintain the study eTMF in an “Inspection Ready” state, ensuring documentation is complete and current.
• Plan and lead audit and regulatory inspection activities, working with the Clinical Quality Associate Director (CQAD) and Quality Assurance teams.
• Contribute insights for process development and ongoing improvement within the organization.
• Keep line managers regularly informed about study status, milestones, key issues, and team performance.
• Ensure full compliance with local policies, codes of ethics, and business practices in all study-related activities.
• Provide feedback on research trends, competing studies, and site/investigator information that can benefit the local market.
• Collaborate with the local Medical Affairs team as needed to support optimal study delivery and scientific quality.
• Actively support SMM initiatives at the local, regional, or global level, as agreed with line management.

Essential Skills/Experience

• Bachelor’s degree
• 5 years of experience
• Demonstrated ability to successfully perform the responsibilities of the role and engage appropriately with internal and external stakeholders.
• Previous experience in the pharmaceutical industry, preferably in Clinical Operations, such as Clinical Research Associate (CRA) or Senior Clinical Research Associate (SrCRA) roles.
• Experience in other related fields, including Medical Affairs-led or academic-led studies, may also be considered.