Local Study Associate Director

Are you ready to lead country execution of pivotal clinical studies and help bring new cancer medicines to patients faster? This is your opportunity to turn global study designs into high-quality local delivery that accelerates recruitment, safeguards data integrity, and advances the standard of care! As a Local Study Associate Director, you will lead cross-functional Local Study Teams to deliver country commitments on time, to budget and quality, and always in line with ICH-GCP and local regulations. You will translate strategy into action, balancing speed with rigor, and removing barriers so investigators and sites can focus on patients. How will you shape country plans that drive performance and elevate quality? You will own end-to-end oversight of country activities—from feasibility and site selection through start-up, monitoring, and close-out—while working closely with global counterparts and local partners. In a science-led, collaborative environment, you will be empowered to anticipate risks, make clear decisions, and continuously improve how we operate at pace.

Accountabilities:

• Country Study Leadership: Own delivery of country commitments, ensuring data quality, adherence to timelines, and budget discipline.
• Local Study Team Management: Lead and optimize performance of CRAs and CSAs, fostering a high-trust, high-performance environment with clear goals and feedback.
• Feasibility and Site Selection: Drive robust country and site feasibility; identify potential investigators, conduct Site Quality Risk Assessments and Site Qualification Visits to select high-performing sites.
• Start-up and Regulatory Interface: Ensure timely, high-quality submissions to Ethics Committees/IRBs and Regulatory Authorities in partnership with Regulatory Affairs for study start-up and throughout the study.
• Budget and Contracts: Prepare and own the country financial Study Management Agreement (fSMA); maintain accurate study budgets and financial records; lead preparation of local Master CSA (including site budgets) and amendments as needed.
• Informed Consent and Essential Documents: Prepare country-level Master Informed Consent Form and site ICFs, including translations; verify collection and correctness of all essential documents before site activation.
• Drug Supply and Local Logistics: Plan and coordinate local drug activities from procurement or reimbursement through to destruction in line with study needs and local requirements.
• Systems and Transparency: Set up and maintain studies in CTMS and any required local systems; ensure critical systems enabling safety reporting, regulatory submissions and clinical trial transparency are accurate and up to date.
• Monitoring Oversight and Quality: Oversee monitoring from activation through closure in accordance with monitoring plans; review monitoring reports; conduct co-monitoring and accompanied visits; step in to perform site monitoring as needed to support flexible capacity.
• Risk Management and Issue Resolution: Develop and maintain the country risk management plan; proactively identify, mitigate and resolve risks, issues, and deviations across sites and vendors.
• Stakeholder Engagement and Recruitment: Lead interactions with investigators, site staff, and national coordinators; shape and implement patient recruitment strategies; plan and lead national investigator meetings in line with local codes.
• Forecasting and Resource Planning: Support forecasting of timelines, resources, recruitment, budget, study materials, and drug supply to secure delivery.
• Training and Coaching: Train and mentor new team members; provide performance insights on CRAs/CSAs to line management; build study capability and consistency.
• Audit/Inspection Readiness and eTMF: Keep the eTMF inspection-ready with timely, complete document upload; lead audit and inspection activities with QA partners; ensure readiness for final archiving.
• Compliance and Ethics: Uphold ICH-GCP, AZ Procedural Documents, local regulations, codes of ethics, and all company policies across people, finance, technology, security and SHE.
• Collaboration and Reporting: Build strong relationships with global study leadership and local Medical Affairs; provide clear, consistent study updates and insights to business partners.
• Continuous Improvement: Contribute to process improvements and SMM initiatives at local, regional, and global levels to enhance efficiency and quality.

Essential Skills/Experience:

• BS in related field, preferably in life science, or equivalent
• Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).
• Strong understanding of international guidelines ICH GCP as well as relevant local regulations.
• Proven track record leading and motivating cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
• Project management skills.
• Team building and interpersonal skills.
• Organizational skills.
• Verbal and written communication skills.
• Ability to prioritize and handle multiple tasks.
• Attention to details.
• Negotiation skills.
• Ability to learn and to adapt to work with IT systems.
• Ability to travel nationally and internationally as required.

Desirable Skills/Experience:

• Medical knowledge and ability to learn relevant AZ Therapeutic Areas.
• Knowledge of the Drug Development Process.
• Understanding of the Clinical Study Process including monitoring.
• Understanding of the Study Drug Handling Process and the Data Management Process.
• Integrity and high ethical standards.
• Analytical skills.
• Resource management skills.
• Decision making and delegation skills.
• Financial leadership skills.
• Change management skills.
• Coaching skills.
• Ability in handling crisis situations.
• Intercultural awareness.

The annual base pay for this position ranges from $137,937.60 - $206,906.40. 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.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility.

When we put unexpected teams in the same room, we ignite ambitious thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca: Here, science leads and curiosity never stops—teams are trusted to push boundaries, fuse innovative technology with deep clinical expertise, and turn bold ideas into medicines that change clinical practice. With a strong track record of delivering new cancer therapies across multiple indications, significant ongoing investment in R&D, and close partnerships with leading academic centers, you will join a community that publishes at the highest levels and learns fast together. We value kindness alongside ambition, empowering leaders at every level to ask questions, take smart risks and collaborate across fields to make a tangible difference for patients facing some of the hardest-to-treat diseases.

Step into a role where your country leadership will accelerate breakthrough studies and improve patients’ lives—make your move and shape what comes next today.

Date Posted

12-Aug-2026

Closing Date

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.