Local Study Associate Director - Remote

AstraZeneca - Wilmington, DE

Full-time - Mid Level

Remote - Wilmington, DE

Chemical Manufacturing

About the position

AstraZeneca is seeking a Local Study Associate Director (LSAD) to lead Local Study Teams (LSTs) at the country level, ensuring the delivery of clinical studies according to agreed resources, budget, and timelines. This remote position requires a strong commitment to compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. The LSAD will be responsible for overseeing the entire study process, from site identification and qualification to monitoring and documentation archiving. This role is crucial in ensuring that clinical trials are conducted efficiently and effectively, with a focus on delivering high-quality data in a timely manner. The LSAD will lead a team consisting of Clinical Research Associates (CRAs) and Clinical Study Associates (CSAs), optimizing their performance to meet study commitments. Responsibilities include conducting feasibility assessments, coordinating site selection, ensuring timely submissions to ethics committees and regulatory authorities, and managing the study budget. The LSAD will also oversee monitoring activities, review monitoring reports, and proactively address any study-related issues that arise. This position requires excellent project management skills, the ability to lead cross-functional teams, and a strong understanding of clinical trial processes and regulations. AstraZeneca values entrepreneurial thinking and collaboration, encouraging team members to seize opportunities for change and innovation. The LSAD will play a key role in building a new kind of organization that resets expectations for what a biopharmaceutical company can achieve. This position offers the chance to make a significant impact on the development of life-changing medicines, working alongside a diverse and inclusive team committed to excellence in clinical research.

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 process.
• Perform site monitoring as needed to support the flexible capacity model.
• Identify and evaluate potential study sites and investigators, conducting Site Quality Risk Assessments and Site Qualification Visits.
• Ensure timely submission of application/documents to Ethics Committees/Institutional Review Boards (EC/IRB) and Regulatory Authorities.
• Prepare and maintain accurate study budgets and financial agreements in the clinical studies financial system.
• 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.
• Set up and maintain the study in the Clinical Trial Management System (CTMS) and local websites as required by local laws.
• Oversee monitoring activities from site activation through to study closure, ensuring adherence to Monitoring Plans.
• Review monitoring visit reports and provide guidance to monitors on study-related matters.
• Identify risks and facilitate resolution of complex study problems.

Requirements

• Bachelor's degree in a related discipline, preferably in life sciences.
• 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 the ability to prioritize multiple tasks.
• Strong team building and interpersonal skills, with excellent verbal and written communication skills.
• Fluency in spoken and written English.

Benefits

• Opportunity to work in a diverse and inclusive environment.
• Chance to impact the development of life-changing medicines.
• Remote work flexibility.
• Professional development opportunities.