【1000～1500万円】【R D】Associate Director Study Alliance Management …

【求人No NJB2283616】
■ 職務内容 / Job Description
Associate Director Study Alliance Management （ADSAM） is accountable/responsible for oversight of related full outsourcing studies to achieve milestones as scheduled with maintenance of quality and mediator among Japan CRO study team Global CRO representative Japan Associate Director Clinical Development （J ADCD） and AZ Global clinical team.

The ADSAM will contribute to optimize an alliance on full outsourcing studies from the planning to the regulatory inspections （e.g. create/improve oversight platform the agreement and Japan specific requirements through influencing global alliance team members and optimize upcoming study operation planning/execution by J ADCD）.

The ADSAM will take capability and skill development for Japan Study Manager （J SM） and contribute to improve related activities in the Japan Development Operations （J DO）.

■ 応募資格（経験、資格等）/ Qualification （Experience Skill etc.）
【経験 / Experience】
＜必須 / Mandatory＞
At least 5 years’ experience in pharmaceutical industries or multinational healthcare organization.
Extensive knowledge of clinical operations project management tools and processes
Proven experience of clinical development / drug development process in various phases of development and therapy areas including health authority GCP inspection.
Proven ability to learn by working in multiple phases TAs and/or different development situations.
Experience from leading clinical projects and deliverables or similar expertise from other areas of drug development （such as pharmaceutical development）.

＜歓迎 / Nice to have＞
Working with external bodies such as co development companies and key opinion leaders as a leading person.
Leadership of significant cross functional change programmes/initiatives

【資格 / License】
＜必須 / Mandatory＞
Bachelor’s Degree

＜歓迎 / Nice to have＞
Medical or biological science or discipline associated with clinical research

【能力 / Skill set】
＜必須 / Mandatory＞
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 relationship building and negotiation skills
Proactively identifies risks and issues and possible solutions
Basic knowledge and experience of quality management

【語学 / Language】
＜必須 / Mandatory＞
日本語 Japanese：ネイティブ
英語 English：英語 English： Business English （Achieve common understanding at the context level with customers）