技能/経験

【経験 / Experience】
＜必須 / Mandatory＞
・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 

＜歓迎 / Nice to have＞
・Working experiences in Clinical Development/ Quality Assurance, especially Oncology experience
・Knowledge of process improvement methodology such as Lean Sigma/Change Management

【資格 / License】
＜必須 / Mandatory＞
・Bachelor’s Degree in Science or related discipline

＜歓迎 / Nice to have＞
・Medical or biological sciences or discipline associated with clinical research. 
・Advanced degree is preferred. 

【能力 / Skill-set】
＜必須 / Mandatory＞
・Excellent Communication and relationship building skills
・Proven ability to prioritize and manage multiple tasks with conflicting deadlines
・Excellent interpersonal skills and proven ability to facilitate team building and team work
・Proactively identifies risks and issues and possible solutions
・Demonstrates ability to prepare and deliver study related training materials
・Demonstrates ability to plan, coordinate, and facilitate internal and external meetings
・Demonstrates professionalism and mutual respect
・Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities
・Proven learning agility
・Basic knowledge and experience of quality management

＜歓迎 / Nice to have＞
・Project management certification 
・Ability to interact widely and effectively within the company at all levels. Good networking skills
・In-depth knowledge of clinical and drug development process
・Fiscal and financial awareness

【語学 / Language】
＜必須 / Mandatory＞
・英語 English：Business English (Achieve common understanding at the context level)
・日本語 : Native