Study Manager, BioPharma CO, Development Operations Division

Responsibilities

• Lead and manage clinical delivery teams of contributing experts to operationally deliver defined clinical studies or project work packages.
• Ensure clinical studies are delivered on time, within cost, and to the appropriate quality standards within Japan R&D.
• Proactively identify risks and issues, developing and implementing possible solutions.
• Plan, coordinate, and facilitate internal and external meetings.
• Prepare and deliver study-related training materials.
• Manage multiple tasks with conflicting deadlines while maintaining high attention to detail.

Requirements

• At least 5 years of experience within the pharmaceutical industry, similar organizations, or academic research.
• Extensive knowledge of clinical operations, project management tools, and processes.
• Strong understanding of ICH-GCP/J-GCP, local regulations, and study management.
• Bachelor’s Degree in Science or a related discipline.
• Native Japanese proficiency and Business English proficiency.
• Proven ability to prioritize tasks and facilitate teamwork in a high-volume environment.

Preferred Qualifications

• Experience in Clinical Development or Quality Assurance, particularly within Oncology.
• Advanced degree in medical or biological sciences.
• Knowledge of process improvement methodologies such as Lean Sigma or Change Management.
• Project management certification.
• Fiscal and financial awareness.

About the Company

AstraZeneca is a forward-thinking BioPharmaceutical company dedicated to delivering life-changing medicines. Our culture is built on inclusion, belonging, and collaboration, where we work as one team to bring new science to patients with high unmet needs.