Local Study Associate Director

AstraZeneca

7d•$137,938 - $206,906•Hybrid

About The Position

This role leads country execution of pivotal clinical studies to accelerate the delivery of new cancer medicines to patients. The Local Study Associate Director will translate global study designs into high-quality local delivery, focusing on accelerating recruitment, safeguarding data integrity, and advancing the standard of care. They will lead cross-functional Local Study Teams to ensure country commitments are met on time, within budget, and with high quality, adhering to ICH-GCP and local regulations. The position involves end-to-end oversight of country activities, from feasibility and site selection through start-up, monitoring, and close-out, in close collaboration with global counterparts and local partners. The role operates in a science-led, collaborative environment, empowering individuals to anticipate risks, make decisions, and improve operational efficiency.

Requirements

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.

Nice To Haves

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.

Responsibilities

Own delivery of country commitments, ensuring data quality, adherence to timelines, and budget discipline.
Lead and optimize performance of CRAs and CSAs, fostering a high-trust, high-performance environment with clear goals and feedback.
Drive robust country and site feasibility; identify potential investigators, conduct Site Quality Risk Assessments and Site Qualification Visits to select high-performing sites.
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.
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.
Prepare country-level Master Informed Consent Form and site ICFs, including translations; verify collection and correctness of all essential documents before site activation.
Plan and coordinate local drug activities from procurement or reimbursement through to destruction in line with study needs and local requirements.
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.
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.
Develop and maintain the country risk management plan; proactively identify, mitigate and resolve risks, issues, and deviations across sites and vendors.
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.
Support forecasting of timelines, resources, recruitment, budget, study materials, and drug supply to secure delivery.
Train and mentor new team members; provide performance insights on CRAs/CSAs to line management; build study capability and consistency.
Keep the eTMF inspection-ready with timely, complete document upload; lead audit and inspection activities with QA partners; ensure readiness for final archiving.
Uphold ICH-GCP, AZ Procedural Documents, local regulations, codes of ethics, and all company policies across people, finance, technology, security and SHE.
Build strong relationships with global study leadership and local Medical Affairs; provide clear, consistent study updates and insights to business partners.
Contribute to process improvements and SMM initiatives at local, regional, and global levels to enhance efficiency and quality.