Study Leader, R&D Development Operations Division

外資製薬メーカーにてStudy Leaderとして臨床試験のリーダー業務

仕事内容

Study Leaderとして臨床試験のリーダー業務を担います。
To deliver clinical studies in Japan
・Manage a cross functional team of clinical experts to
operationally deliver defined clinical studies or assigned
・Provide input into study start up activities (e.g. study feasibility, study specifications, vendor/partner contracts, authoring of
clinical study protocols and budgeting including authorization and governance of payment).

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】

・Bachelor’s Degree in Science or related discipline
・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

・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 (Speaking level 7 or above, Achieve common understanding at the context level)

【歓迎経験】

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

【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

6ヶ月

勤務地

大阪

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

フレックス制度あり　コアタイムなし

休憩時間

60分

時間外労働

有

勤務開始日

応相談

休日休暇

完全週休2日制(土・日)、祝日、年末年始(6日)、年間休日122日(2009年実績)、年次有給休暇(初年度は入社日に応じて変わりますが、次年度からは1月1日で20日間が毎年付与されます。)、慶弔・赴任・リフレッシュ、頭痛休暇ほか

年収・給与

年収　　～1100万円　経験により応相談

諸手当

住宅手当、通勤手当、単身赴任手当、休日手当ほか

昇給

年１回

賞与

年間標準6ヶ月

採用人数

1名　

待遇・福利厚生

【待遇】

社宅制度、厚生年金基金、退職年金、財形貯蓄、融資制度、持株会制度、各種社会保険、リスクベネフィット（特別弔慰金、入院見舞金及び治療給付金、災害補償）、ほか慶弔見舞金マルティプル・エンプロイメントシステム、ストックボーナス

【福利厚生】

選考プロセス

１）書類選考
２）一次面接
３）二次面接
４）最終面接