Local Study Associate Director

Local Study Associate Director

Introduction to role

Are you ready to take on a pivotal role in clinical study management? As a Local Study Associate Director (LSAD) at AstraZeneca, you'll lead Local Study Teams to ensure the successful delivery of country-level study commitments. You'll manage clinical studies with precision, adhering to AstraZeneca's procedural documents, international guidelines like ICH-GCP, and local regulations. Reporting to either the Director Country Head or Director Site Management & Monitoring, you'll collaborate with the Global Study Team to drive study success. Your leadership will extend beyond team management, as you may also engage in site monitoring activities, ensuring study sites are effectively identified, qualified, and monitored throughout the study lifecycle.

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/IRBs and, in partnership with Regulatory Affairs, supports 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 set-up and ongoing management of studies within CTMS, 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.

• Coordinates closely with National Coordinating Investigator or National Lead Investigator on recruitment and other study matters, when applicable.

• Plans and leads National Investigator Meetings in alignment with local codes, as needed.

• Assists with forecasting for study timelines, resource needs, recruitment, budgeting, materials, and investigational product supply.

• Ensures set-up, 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, or site/investigator information that can benefit the local market.

• Collaborate with the local Medical Affairs team as needed for 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
Education and experience:

• Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification aligned to the knowledge and skills of the role and ensures successful conduct of responsibilities and appropriate interactions with internal and or external stakeholders.

• Previous experience in the pharmaceutical industry, preferably in Clinical Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies)

• Relevant knowledge and ability to fulfil key responsibilities, including but not limited to: Drug development process and related GxP processes, International guidelines ICH-GCP, relevant country regulations, medical knowledge and ability to learn relevant AZ Therapeutic Areas, Clinical Study Management including project management, monitoring, study drug handling and data management.

• Role-Required Skills: • Personal Effectiveness & Drives Accountability in Others • Learning Agility • Financial, Technology & Process Competency • Active Listening, Fluency in written & spoken business-level English • Act with Integrity & high ethical standards • Effectively lead a team across in-person and virtual settings to deliver shared goals, demonstrates cultural awareness • Identify and champion more efficient delivery of quality clinical trials with optimised cost and time • Ability to travel nationally/internationally as required • Valid driving license, if country employment requirement • Communication & Teamwork - Influencing, Collaboration, Impactful Site conversations • Effective, risk-based thinking – Plans & Aligns, Strategic thinking, Problem Solving, Critical Thinking, Decision Making, Effective Issue Management • Clinical Study Operations (GCP) & Quality Management - RbQM: Interpreting and implementing the Monitoring Plan, Study site selection & set-up • Deliver Priorities Results & Impact - Project Management, Recruitment/Retention Planning & Action.

Why AstraZeneca?

At AstraZeneca you'll be part of a dynamic team tackling some of the most complex challenges in medicine development. With access to extensive capabilities and a comprehensive pipeline, you'll be involved in countless submissions across various therapy areas. Our fast-paced environment encourages innovation and experimentation. We value dedication and courage—qualities that drive us forward even when facing unknowns. Here you'll find an inspiring learning environment where setbacks are seen as opportunities for growth. Join us in making a profound impact on patients' lives through research that truly matters.

Ready to make a difference? Apply now!

Date Posted

10-Nov-2025

Closing Date

13-Nov-2025

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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 authorisation and employment eligibility verification requirements.