大手外資製薬メーカーにてR&D　Study Manager

募集要項

仕事内容

'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.

応募条件

【必須事項】

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
Bachelor’s Degree in Science or related discipline
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
英語 English：Business English (Achieve common understanding at the context level)

日本語 : Native

【歓迎経験】

Working experiences in Clinical Development/ Quality Assurance, especially Oncology experience
Knowledge of process improvement methodology such as Lean Sigma/Change Management
Medical or biological sciences or discipline associated with clinical research.
Advanced degree is preferred.
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

【免許・資格】

特になし

【勤務開始日】

応相談

学歴

大学卒以上

雇用形態

正社員

試用期間

3ヶ月

勤務地

転勤の有無

転勤なし

受動喫煙防止措置

敷地内禁煙（喫煙場所なし）

勤務時間

フレックスタイム制
フルフレックス（コアタイムなし）
標準勤務時間帯: 9:00～17:15 （所定労働時間：7時間15分）

勤務開始日

応相談

休日休暇

年間休日数：123
土日祝
年間有給休暇：入社半年経過時点12日（入社月に応じて4日～最高20日）　 ～ 20日
法定休暇：年次有給休暇、産前産後休暇
その他休暇：リフレッシュ休暇、頭痛休暇他

年収・給与

年収　　600万円～1300万円　経験により応相談

諸手当

通勤手当、単身赴任手当、休日手当ほか

昇給

年１回

賞与

有

採用人数

若干名

待遇・福利厚生

通勤手当：有
確定拠出年金、財形貯蓄制度・持株会制度・慶弔見舞金・健康診断・福利厚生倶楽部ほか

各種制度

健康保険：有
雇用保険：有
労災保険：有
厚生年金：有
退職金制度：有

選考プロセス

１）書類選考
２）適性検査
３）一次面接
４）最終面接