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Clinical Trial Supplies Specialist, Clinical Trial Supply Group, CMC Dept,

年収:800万 ~ 1200万

ヘッドハンター案件

部署・役職名 Clinical Trial Supplies Specialist, Clinical Trial Supply Group, CMC Dept,
職種
業種
勤務地
仕事内容 Description:

・This position is responsible for project management of the trial timelines and holding the enabling functions accountable for agreed deliverables for global IMP supply chain activities in support of national and international phase I - IV clinical trials. And ensures the timely provision of clinical supplies for assigned trials.
・This position is also responsible for supporting IMP supply chain for Japan in cooperation with internal and external partners.

Duties & Responsibilities:
1.Trial Manager CTSU role as a member of Global CTSU
Fulfill TrM-CTSU's accountabilities
Lead the Global CTSU Trial Team
Ensure timeline and qualiy of clinical supplies
Ensure supply chain management
Ensure transparency of trial preparation proces
Encourage innovations

2.Support Global CTSU activities related to Japan
Support global CTSU activities such as distribution, IRT, label text for Japan as a member of Global CTSU
Control and maintain retention/reserve sample storage for KPRI IMP-GMP materials management

3.Support ClinOps Japan for successful clinical trial in Japan
Provide IMPs import/destruction services in compliant with local regulation
Provide local IMP-related information in timely manner
Act as the deputy of IMP Administration Manager in KPRI GMP organization

4.Ensure compliance to GxP and all relevant regulatory requirements
Ensure no critical findings during authorities' inspections
Ensure approval of NMEs according to agreed timeline

5.Leading changes in clinical trial supply process with Global CTSU and Medicine
Analyze gaps IMP-related processes
Plan and implement changes in processes in line with partners
Monitor changes

6.Take Project Manager tasks for selected projects (temporarily and/or as development plan)
Act as TM CTSU in R&D Subteams and Medical Subteams
Ensure bulk drug product planning
応募資格

【必須(MUST)】

Requirements:
Masters Degree eg MBA or MSc
8-10 years of experience in an international pharmaceutical R&D organization
Leading employees experience
Leading projects experience
Deep understanding of logistics of IMP and clinical trial conduct
International work experience (cross-cultural/functional competence)
Profound understanding of relevant regulations, especially GCP, GDP, PIC/S,IMP-GMP, and import-export related regulations
Profound knowledge of conduct of clinical trials and the manufacture of clinical supplies
Profound knowledge of supply chain management and logistics

更新日 2019/12/03
求人番号 1198691

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