Director, Site Management & Monitoring

Responsibilities

• Lead and manage a dedicated team to ensure the successful delivery of clinical interventional studies.
• Oversee resource planning, budget oversight, and performance monitoring for direct reports.
• Ensure all study activities comply with ICH-GCP, AstraZeneca procedural documents, and local regulations.
• Manage study site identification, qualification, setup, monitoring, and closure processes.
• Oversee the completeness and timeliness of the electronic Trial Master File (eTMF) to ensure inspection readiness.
• Provide coaching, mentorship, and professional development support to the SMM team.
• Contribute expertise to high-quality feasibility assessments for clinical studies.
• Collaborate with the Country Head and local Medical Affairs to ensure functional alignment and operational efficiency.

Requirements

• BSc degree in a relevant field.
• 6+ years of professional work experience in clinical research or a related field.
• Strong knowledge of ICH-GCP guidelines and the Clinical Study Process.
• Proven expertise in Feasibility and Project Management processes.
• Experience in Therapeutic Area (TA) management and leading professional teams.
• GCP certification.
• Proficiency in both Korean and English.

About the Company

AstraZeneca is a forward-thinking BioPharmaceutical company dedicated to delivering life-changing medicines. We embrace diversity and equality, fostering an inclusive environment where innovation and collaboration drive our mission to help patients worldwide.