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キービジュアル キービジュアル
更新日 2018-12-08
掲載開始日 2018-12-07

Clinical Trial Manager

  • ★★ スタッフレベル
この求人の
取扱い会社
人材紹介
Michael Page Japan
企業名 Global Biopharmaceutical Company
職種
Michael Page Japan
メディカル/医薬/バイオ/素材/食品 - 臨床開発系
業種 製薬メーカー
勤務地 アジア 日本 東京都

仕事内容 *

Provide local expertise for conducting clinical trials and manage Japan portion of clinical trial to meet timelines, milestones and regulatory requirements
*

In partnership with Global Clinical Operations, oversee CRO for ensuring clinical trial, by conducting accompanied monitoring visits and assisting with the resolution of specific operational issues


Description

* Provide guidance and training to CROs, venders, investigators and study coordinators on study

* Prepare and/or review the relevant parts of any regulatory documents for clinical trial

* Establish good relationship with investigators and manage them to accelerate the development

* Conduct translation QC and archive clinical trial documents appropriately

* Oversee study sites and CRO, by performing source data verification and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, Monitoring Plan and TMF plan as required

* Contribute to process standardization, develop /maintain local SOPs in Japan

* Prepare and maintain the Post Marketing Surveillance (PMS) collaborating with Late Phase team, if needed


Profile

* The position is responsible for successful study completion reporting to the manager of Clinical Operation Japan

* Must have demonstrated capability to manage multiple tasks simultaneously, plan proactively and accomplish goals using well-defined instructions and procedures

* Experience in clinical development and/or project management

* Experiences in oversight of CROs and vendors

* Experiences in GCP/ source data verification (also PMDA inspection of clinical trial, if any) 

* Through knowledge and understanding of Japanese Regulations, ICH Guidelines and GCPs governing the conduct of clinical trials is required 

* Experiences in managing KOLs, if any


Job Offer

* Contribute directly to improving the care of patients living with life-threatening diseases at a leading science based biopharmaceutical company

* Relatively small organization with Japan, opportunity to develop across a broad range of responsibilities


Page Group Japan is acting as an Employment Agency in relation to this vacancy.
企業について
(社風など)
* Major US biopharmaceutical research company specializing in producing treatments for cancer, major infectious diseases and liver disease
英語能力 流暢 (TOEIC 865点以上)
日本語能力 ネイティヴレベル
年収 経験と能力に基づく   
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Clinical Trial Manager

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