• Responsible for leading and managing clinical delivery team of contributing experts to operationally deliver defined clinical studies, or clinical project work package / activities to time, cost and appropriate quality in Japan R&D.
• Clinical Operations is the organisational home for the operational delivery and programme and project management of clinical projects, drug and non-drug.

Requirements

At least 5 years’ experience from within the pharmaceutical industry or similar organization or academic experience
Extensive knowledge of clinical operations, project management tools and processes
Understanding of the skills and knowledge required for the successful delivery of a clinical study, e.g. ICH-GCP/J-GCP, local regulations, study management
Good experience of clinical development / drug development process in various phases of development and therapy areas
Working experiences in Clinical Development/ Quality Assurance, especially Oncology experience
Knowledge of process improvement methodology such as Lean Sigma/Change Management
Bachelor’s Degree in Science or related discipline
Advanced degree is preferred
Business English and Native Japanese

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Hard Skills

clinical operations
project management
clinical study delivery
drug development process
quality assurance
process improvement methodology
Lean Sigma
Change Management

Soft Skills

leadership
team management
communication

Certifications & Qualifications

Bachelor’s Degree in Science
Advanced degree

Study Manager, BioPharma

Community Operations Coordinator