LSAD (Local Study Associate Director)

AstraZeneca plc; Wilmington (DE); On-site; USD 138,000 - 207,000; Full time

Benefits offered by this job

Short-term incentive bonuses

Equity-based awards

Retirement programs

Health/dental/vision coverage

Paid time off

Job summary

AstraZeneca is looking for a Local Study Associate Director (LSAD) to manage assigned clinical studies and lead Local Study Teams. You will ensure delivery within budgets, timelines, and local regulations, while coordinating with Global Study Team and country leads to optimize patient recruitment and study quality.

The role requires strong leadership, ICH-GCP knowledge, and extensive stakeholder engagement in a global pharma setting.

Qualifications

• Bachelor’s degree required and relevant pharma experience.
• Minimum 5 years of experience in clinical operations or CRA/SrCRA roles.
• Experience engaging with internal and external stakeholders in pharma.
• Strong knowledge of ICH-GCP and regulatory requirements.
• Ability to lead local study teams and manage country-level study commitments.

Responsibilities

• Lead Local Study Teams to deliver country-level study commitments.
• Ensure study sites are qualified, initiated, and monitored per SOPs and regulatory requirements.
• Oversee site selection, ethics submissions, and regulatory interactions.
• Manage budgets, timelines, and resources with alignment to DCH/DSMM guidance.
• Coordinate with GST and national investigators to support patient recruitment.

Skills

Leadership

Stakeholder management

Communication

ICH-GCP knowledge

Education

Bachelor’s degree

Tools

CTMS

eTMF

Regulatory submissions systems

Job description

Job Title: LSAD (Local Study Associate Director)

Location: Field

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we're taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

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 escape 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.

Where can I find out more?

• Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
• Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
• Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
• Our US Footprint: Powering Scientific Innovation - YouTube

Compensation & Benefits

The annual base pay (or hourly rate of compensation) for this position ranges from $137,937 to $206,906. Our positions offer eligibility for various incentives - an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Equal Opportunity Employer Statement

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing [e-mail].

Additional Information

Only happy to fill job code #LI-Hybrid. Date Posted: 23-Oct-2026. Closing Date: 01-Nov-2026.

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.