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.
You will:- 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.
You have:- 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.
Desirable Skills:- 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.
So, what's next? Are you already imagining yourself joining our team? Good, because we can't wait to hear from you!
The annual base pay for this position ranges from $137,937.60 - $206,906.40. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Date Posted27-Jun-2026
Closing Date07-Jul-2026
