メディカル・バイオ - 臨床開発モニター
メディカル・バイオ - 臨床開発リーダー・臨床開発プロジェクトマネージャー

■ 職務内容 / Job Description

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.

■休日：完全週休二日制, 年末年始

■ 応募資格（経験、資格等）/ Qualification (Experience & Skill etc.)

【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＞
・Project management certification
・Working experiences in Clinical Development/ Quality Assurance
・PMDA GCP inspection

【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.

【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
・Basic knowledge and experience of quality management

＜歓迎 / Nice to have＞
・Ability to interact widely and effectively within the company at all levels. Good networking skills
・Knowledge of process improvement methodology such as Lean Sigma/Change Management
・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 with customers)

■職種未経験者：不可