Local Study Associate Director

AstraZeneca

6d • $137,938 - $206,906 • Hybrid

About The Position

As a Local Study Associate Director, you'll lead Local Study Teams (LSTs) to successfully deliver country-level clinical studies while ensuring compliance with AstraZeneca Procedural Documents, ICH-GCP guidelines, and local regulatory requirements. You'll be responsible for the end-to-end execution of studies, from feasibility and site selection through study start-up, monitoring, closeout, and inspection readiness. Working closely with global and local cross-functional partners, you'll drive operational excellence, proactively manage study risks, and ensure high-quality data delivery. As needed, you'll also perform site monitoring activities to support AstraZeneca's flexible capacity model.

Requirements

• Bachelor's degree in Life Sciences or a related discipline (or equivalent qualification).
• Minimum 5 years of experience in Clinical Operations, Study Management, CRA, Senior CRA, or related clinical research roles within the pharmaceutical, biotechnology, CRO, or academic research environment.
• Strong knowledge of ICH-GCP, FDA/EMA guidelines, and applicable local regulations.
• Experience leading cross-functional study teams and managing country-level clinical study execution.
• Excellent project management, communication, organizational, and stakeholder management skills.
• Ability to manage multiple priorities while delivering high-quality results.
• Willingness to travel domestically and internationally as required.

Nice To Haves

• Advanced degree in Life Sciences or related field.
• Clinical study delivery leadership experience.
• Strong understanding of the drug development process.
• Experience with CTMS, eTMF, and clinical trial systems.
• Knowledge of patient safety, regulatory submissions, and data management processes.
• Project Management certification or equivalent experience.
• Experience supporting regulatory inspections and audits.
• Coaching, mentoring, and cross-functional leadership experience.

Responsibilities

• Take full responsibility for country-level study delivery, ensuring timelines, quality, budget, and regulatory commitments are achieved.
• Lead and mentor Local Study Teams consisting of CRAs and CSAs for assigned studies.
• Drive operational excellence while ensuring compliance with AstraZeneca SOPs, ICH-GCP, and local regulations.
• Conduct clinical and operational feasibility assessments for new studies.
• Coordinate site identification, qualification, selection, initiation, monitoring, and closeout activities.
• Perform Site Qualification Visits and Site Quality Risk Assessments.
• Ensure timely submissions to Ethics Committees (EC/IRB) and Regulatory Authorities throughout the study lifecycle.
• Prepare and maintain study budgets, financial agreements, and country-level study documentation.
• Develop Master Informed Consent Forms (MICFs) and ensure compliance with local regulations.
• Verify trial essential documents and ensure sites are inspection-ready prior to enrollment.
• Coordinate investigational product activities, including procurement, distribution, reimbursement, and destruction.
• Oversee monitoring activities in accordance with Monitoring Plans and provide guidance to CRAs through monitoring report reviews and co-monitoring visits.
• Proactively identify, assess, and mitigate study risks while resolving complex operational issues.
• Lead Local Study Team meetings and maintain strong collaboration across global and local stakeholders.
• Report study progress, milestones, and risks to the Global Study Associate Director and Global Study Team.
• Support patient recruitment strategies and maintain regular communication with investigators.
• Develop and maintain country-level risk management plans.
• Lead National Investigator Meetings when applicable.
• Forecast study timelines, recruitment, resources, budgets, investigational product, and study materials.
• Ensure business-critical systems (CTMS, Safety Reporting, Regulatory, Clinical Trial Transparency) are maintained and up to date.
• Ensure timely and accurate study payments according to local regulations.
• Train and coach new Local Study Team members on AstraZeneca procedures and ICH-GCP.
• Maintain an inspection-ready eTMF by ensuring timely upload of essential documents.
• Lead country-level audit and regulatory inspection activities in partnership with Quality.
• Drive continuous process improvements and operational excellence initiatives.
• Provide regular updates to line management on study milestones, risks, and CRA/CSA performance.
• Ensure compliance with AstraZeneca's Code of Ethics, company policies, and Safety, Health & Environment (SHE) standards.

Benefits

• Qualified retirement program (401(k) plan)
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior