Job detail for R&D Clinical Operations, Sr. Business Analyst

Job Description

In our Clinical Business Management department—which is responsible for resource management, sourcing strategy development and execution, supplier management, project budget planning and control, and KPI management across the entire Clinical Operations area to ensure trial success—we are introducing a new Business Analyst (BA) role within our global operations organization.

This position is responsible for driving the transformation of clinical trial operations by leveraging technology and data, while leading improvements in productivity, quality, and compliance in collaboration with global leadership and various countries.

You will be responsible for conceptualizing, introducing, and ensuring the adoption of solutions utilizing Automation, data analytics, and AI to address operational challenges in clinical development in Japan. In performing these duties, you will work closely with existing AI and Automation task forces within Clinical Operations (CO), and in the future, you are expected to collaborate on related initiatives deployed across the entire Research & Development division. Furthermore, through collaboration with global teams and other countries, you will be expected to contribute to global operations by promoting the optimization of local solutions and their deployment to other countries.

We are looking for individuals who are motivated to create new value by solving on-site challenges and to share and deploy the results achieved in Japan to the global organization.

【Position/Job Level/Grade】

Senior Business Analyst (Sr. BA) / P3

【Key 】

・Collaborate with the Clinical Operations leadership team and global teams to create high value by utilizing Automation, data analytics, and AI.

・Lead the entire process from identifying issues, organizing requirements, and evaluating solutions to implementation, deployment, and adoption, while introducing and deploying solutions optimized for the whole through coordination with various stakeholders.

・Ensure compliance with ICH GCP, internal policies, and domestic regulations, and coordinate with Compliance, Legal, IT, and external vendors as necessary to ensure security, privacy, and quality.

【Required Qualifications】

・Several years of experience in clinical development operations and in roles related to data/analytics, process improvement, and transformation through technology utilization in the life sciences/healthcare sector.

・Communication skills to collaborate smoothly with internal and external stakeholders.

・Business-level English proficiency: Communication skills to discuss with overseas colleagues and global teams and proactively contribute to solving operational issues and decision-making.

・Ability to logically organize issues and propose and execute solutions.

【Preferred Qualifications】

・Knowledge/experience in Clinical Operations or clinical trial processes.

・Experience in cross-functional coordination and project management.

・Understanding of the basic principles of ICH GCP, quality, data privacy, and information security.

・Experience in system/data integration with IT/Data Science departments or coordination with external vendors.

【Other】

Flexible work hours without core time apply (Refer to: Flexible Work Hours System Regulations without Core Time)

Required Skills:

Artificial Intelligence (AI), Automation, Change Management, Clinical Development, Cross-Functional Collaboration, Data Analytics, English Language, Global Communications, IT Business Solutions, Japanese Language, Leadership, Logical Thinking

Preferred Skills:

Clinical Operations, ICH GCP Guidelines, Project Management

Current Employees apply HERE

Current Contingent Workers apply HERE

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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

12/31/2026

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