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【R&D】Study Leader, Development Operations Division

Location Osaka, Ōsaka, Japan Kita-ku, Tokyo, Japan Job ID R-161509 Date posted 20/03/2023

■ 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. 

■ 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>

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

【キャリアレベル / Career Level】


【勤務地 / Work Location】

Osaka or Tokyo

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

50056678 D CDSM

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.