LSAD (Local Study Associate Director)

AstraZeneca

5d•$137,937 - $206,906

About The Position

The Local Study Associate Director (LSAD) manages assigned clinical studies and leads Local Study Teams to deliver country-level study commitments within agreed budgets, timelines, and resources. The role works in alignment with the Global Study Team and reports to the Director Country Head or Director Site Management & Monitoring, depending on the country’s organizational structure. The LSAD may also perform site monitoring activities as part of a flexible capacity model. The LSAD ensures that study sites are identified, qualified, set up, initiated, monitored, and closed, and that site documentation is archived according to required standards. Study activities must comply with AstraZeneca procedural documents, ICH-GCP guidelines, and relevant local regulations. The position also supports country-level study submissions, financial management, recruitment, risk management, inspections, and continuous process improvement.

Requirements

Bachelor’s degree.
At least 5 years of experience.
Demonstrated ability to perform the role’s responsibilities and engage appropriately with internal and external stakeholders.
Previous pharmaceutical industry experience.

Nice To Haves

Clinical Operations experience, such as working as a Clinical Research Associate (CRA) or Senior Clinical Research Associate (SrCRA).
Experience in related fields, including Medical Affairs-led or academic-led studies, may also be considered.

Responsibilities

Fulfill country-level study commitments and ensure timely, high-quality data delivery.
Lead Local Study Teams, including CRAs, CSAs, and other contributors, and foster collaboration and high performance.
Drive team performance and compliance with AstraZeneca procedural documents, ICH-GCP requirements, and local regulations.
Support clinical and operational feasibility assessments of potential studies.
Coordinate site selection, identify potential sites and investigators, conduct initial site quality risk assessments, and perform Site Qualification Visits when needed.
Ensure timely submission of applications and documentation to Ethics Committees/IRBs and support Regulatory Authority submissions with Regulatory Affairs.
Prepare country-level financial agreements and maintain study budgets in the clinical financial system, coordinating with relevant study and finance leaders.
Set up and manage studies in CTMS, eTMF, study finance systems, and other required tools or local platforms.
Oversee and coordinate monitoring activities from site activation through closure, review monitoring visit reports, and guide monitors.
Conduct co-monitoring, accompanied site, and training visits with study CRAs as required.
Identify risks, resolve complex study problems, and escalate issues as necessary.
Organize and lead regular Local Study Team meetings and maintain effective communication and teamwork.
Build and maintain relationships with Local Study Team members, site staff, and global stakeholders.
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 contact with investigators to support enrolment goals.
Develop and maintain a study-level country risk management plan and manage sites, stakeholders, vendors, and customers to identify and mitigate risks.
Coordinate 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.
Support forecasting for study timelines, resources, recruitment, budgets, materials, and investigational product supply.
Ensure country-level setup, updates, and access for business-critical systems covering safety reporting, regulatory submissions, and clinical trial transparency.
Ensure study payments are accurate and compliant with local regulations and agreements.
Train and coach new Local Study Team members to support quality and adherence to ICH-GCP and AstraZeneca procedures.
Maintain the study eTMF in an inspection-ready state, with complete and current documentation.
Plan and lead audits and regulatory inspections in collaboration with the Clinical Quality Associate Director and Quality Assurance teams.
Contribute insights to process development and continuous improvement.
Keep line managers informed about study status, milestones, key issues, and team performance.
Ensure compliance with local policies, codes of ethics, and business practices in study-related activities.
Provide feedback on research trends, competing studies, and site and investigator information relevant to the local market.
Collaborate with local Medical Affairs as needed to support study delivery and scientific quality.
Support SMM initiatives at local, regional, or global level, as agreed with line management.