外資大手製薬メーカー Study Manager, R&D, Development Operations, Late Development Oncology
- 会社区別外資系製薬メーカー
- 職種Study Manager, R&D, Development Operations, Late Development Oncology
- 勤務地大阪市北区、東京都港区
- 年収700万円～1,100万円
資格・要件
＜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
＜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
Critical/Logical thinking
＜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 Level (Comfortable speaking in conference setting, Achieve common understanding at the context level)
日本語: Native/Proficient
職務内容
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.
【その他情報】
契約期間：期間の定めなし
試用期間：6か月
就業時間：9:00～17:15
休憩時間：60分
フレキシブルタイム：あり
時間外労働：あり
休日休暇：
完全週休2日制（休日は土日祝日）
年間有給休暇 初年度12日
年間休日日数121日
■公休日：完全週休2日制(土、日)・祝日・年末年始6日
■休暇：年次有休休暇・慶弔・赴任・リフレッシュ
受動喫煙対策：あり 就業場所 全面禁煙
加入保険：雇用・労災・健康・厚生年金保険
在宅勤務制度：有
