Local Study Associate Director at AstraZeneca

, , United States -

Full Time

Start Date

Immediate

Expiry Date

26 Sep, 26

Salary

206906.4

Posted On

28 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Operations, Study Management, ICH-GCP, Project Management, Stakeholder Management, Site Monitoring, Regulatory Compliance, Risk Management, Budget Management, Clinical Trial Execution, Mentoring, Cross-functional Leadership

Industry

Pharmaceutical Manufacturing

Description

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. Why AstraZeneca? At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare. 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 Posted 27-Jun-2026 Closing Date 07-Jul-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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

Lead Local Study Teams to deliver country-level clinical studies while ensuring compliance with regulatory requirements and ICH-GCP guidelines. Manage the end-to-end execution of studies, including feasibility, site selection, monitoring, and inspection readiness.