AstraZenecaR&DStudy Manager, BioPharma CO, Development Operations Division

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

• Bachelors 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 EnglishBusiness English (Achieve common understanding at the context level)

日本語 : Native

キャリアレベル / Career Level

D

勤務地 / Work Location

Osaka or Tokyo

Date Posted

Closing Date

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.