Local Study Associate Director - Remote

AstraZeneca - Wilmington, DE

Full-time - Mid Level

Remote - Wilmington, DE

10,001+ employees

Chemical Manufacturing

About the position

The Local Study Associate Director (LSAD) at AstraZeneca plays a pivotal role in leading Local Study Teams (LSTs) at the country level to ensure the successful delivery of clinical studies. This position is integral to the clinical development process, ensuring that studies are conducted in compliance with AstraZeneca's procedural documents, international guidelines such as ICH-GCP, and relevant local regulations. The LSAD is responsible for overseeing the entire lifecycle of clinical studies, from site identification and qualification to monitoring and closure, ensuring that all commitments are met within the agreed resources, budget, and timelines. In this remote position, the LSAD will lead a team of Clinical Research Associates (CRAs) and Clinical Study Associates (CSAs), optimizing their performance to ensure compliance and high-quality delivery of clinical trials. The LSAD will coordinate the site selection process, conducting thorough assessments of potential sites and investigators, and ensuring that all necessary documentation is submitted to ethics committees and regulatory authorities in a timely manner. This role also involves managing the financial aspects of the studies, including the preparation of study management agreements and maintaining accurate budgets. The LSAD will be proactive in identifying risks and resolving complex study-related issues, ensuring that monitoring activities are conducted according to the established plans. This position requires excellent project management skills, the ability to lead cross-functional teams, and a strong understanding of clinical trial operations. The LSAD will also be responsible for maintaining the study in the Clinical Trial Management System (CTMS) and ensuring compliance with local laws and regulations throughout the study lifecycle.

Responsibilities

• Lead Local Study Teams (LSTs) at the country level to deliver clinical studies according to agreed resources, budget, and timelines.
• Ensure compliance with AZ Procedural Documents, ICH-GCP, and local regulations throughout the study lifecycle.
• Coordinate the site selection process by identifying potential sites/investigators and conducting Site Qualification Visits.
• Ensure timely submission of application/documents to Ethics Committees/Institutional Review Boards (EC/IRB) and Regulatory Authorities.
• Manage the financial aspects of the study, including preparation of Study Management Agreements and maintaining accurate budgets.
• Collect and verify all essential trial documents required by ICH-GCP prior to study start.
• Plan and coordinate local drug activities, including purchase, reimbursement, and destruction of drugs.
• Set up and maintain the study in the Clinical Trial Management System (CTMS) and local websites as required.
• Oversee monitoring activities from site activation through to study closure, ensuring adherence to Monitoring Plans.
• Proactively identify risks and facilitate resolution of complex study problems.

Requirements

• Bachelor's degree in a related discipline, preferably in life sciences, or equivalent qualification.
• Minimum of 3 years of experience in Development Operations (CRA, Sr CRA) or related fields.
• Good knowledge of international guidelines ICH-GCP and relevant local regulations.
• Proven ability to lead and motivate cross-functional teams to deliver clinical trials on time and within budget.
• Excellent project management skills and organizational abilities.
• Strong team building and interpersonal skills.
• Excellent verbal and written communication skills in English.
• Ability to prioritize and handle multiple tasks effectively.

Nice-to-haves

• Experience in Medical Affairs-led or Academic-led studies.
• Familiarity with Clinical Trial Management Systems (CTMS).
• Knowledge of local regulations and compliance requirements.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health insurance coverage.
• Retirement savings plan with company matching contributions.
• Opportunities for continued education and professional development.
• Flexible working hours and remote work options.
• Employee wellness programs and resources.