Clinical Project Manager

東京23区 外資系企業 外資系企業
  • Responsible for Project Management of PI-PIV of Regenerative Medicine Trials
  • Work Anywhere in Japan

企業情報

  • Promising global bioventure with JNDA planned this summer.
  • Specialized first in class regenerative therapy.

職務内容

  • Responsible for overseeing, supporting and supervising the CRO partner involved in management of the trials.
  • Ensure adherence to established guidelines and standards, such as GCP regulations, resulting in a high quality output.
  • Support data management activities required to report data obtained from previous trials.
  • Close coordination with senior management and with other disciplines within the company to effectively manage all involved activities.
  • Senior Additional responsibility for managing enquiries from PMDA and planning PMS studies.

理想の人材

  • Working knowledge of ICH/JGCP guidelines and other regulations applicable to clinical project management
  • Proven experience in clinical project management in a relevant organisation
  • Demonstrated ability to manage late phase trials
  • Experienced in working with a CRO, and being responsible for oversight, support and surveillance of the tasks assigned to the CRO
  • Knowledge of data management procedures, and experience in supporting a data management vendor from cleaning study data, through database lock and final study report
  • Self-motivated with ability to work independently with moderate supervision
  • Organisation and experience working to deadlines
  • Judgement and problem solving abilities to identify solutions to routine issues and seek guidance on more complex issues
  • Strong interpersonal skills with ability to build consensus and work effectively in teams
  • Current with relevant legislation and guidance
  • Fluent Japanese, business level English
  • Excellent attention to detail
  • Excellent organisational skills with ability to manage priorities and work effectively and efficiently under pressure
  • Knowledge and/or experience with cellular therapies preferred

条件・待遇

  • Opportunity to contribute to approval of new regenerative therapy in an area of unmet medical needs
  • Contribute directly to the start-up activities of a global bioventure company in Japan
  • Opportunity to work anywhere in Japan
コンタクト
Ed Marsden
求人番号
4191209
電話
+813 6832 8981

求人情報

勤務地
雇用形態
担当コンサルタント
Ed Marsden
担当コンサルタントの電話番号
+813 6832 8981
求人番号
4191209
企業タイプ