クリニカルオペレーションズジャパンストラテジックフィジビリティ/開発企画/プロジェクトマネージャー 【製薬オンライン】製薬会社・製薬メーカー・製薬企業・医薬品・医療機器等の製薬・医療業界の求人転職サイト

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製薬業界専門の転職・求人サイト 製薬Online.com
最終更新日: 2018年 09月 19日

求人情報

開発企画/プロジェクトマネージャー

求人管理No.012850

クリニカルオペレーションズジャパンストラテジックフィジビリティ

Lead and coordinate Country feasibility assessment for all clinical studies to be conducted in Japan to ensure COJ involvement in global trials to achieve its vision

募集要項

・Lead and coordinate the strategic feasibility assessment and CDP input for all global Projects in Japan by liaison with both local and global stakeholders, including but not limited to Global feasibility management, TACOL, COJ relevant functions, NBI Clinical Development, and Medical Affairs (CDMA) , Drug Regulatory Affairs and other JPT contributing functions


Take innovative approach to enhance the effectiveness of strategic feasibility to ensure the success of a study planning


Support strategic Feasibility in Asia (outside Japan) when requested


・Timely input to global strategic feasibility

・ Feedback from stake holders

・ value added input to CDP, global strategic feasibility

・Impact of the feasibility on productivity and efficiency

・Contribute of patients to both global and local registration



・Liaise with other COJ leadership members and various stakeholders within NBI and global ( if applicable) to develop strategy of proper EE engagement at both global and regional levels in different trials.


・Establish governance process within COJ for COJ members contribution to JPT.

work closely with applicable COJ leadership members to provide oversight and governance to COJ members activities related to JPT


・Governance process established

・ feedback from stakeholder on COJ input


・Lead and coordinate country allocation process within COJ:

・Liaise with other COJ leadership team member to secure resources for country allocation process when required

coordinate with designated resources to device specific plan for country allocation feasibilitybasedonstudyrequirements
To implement the specific plan for country allocation feasibility as required by study
Consolidate results and communicate with global
Develop innovative approach for allocation feasibility to improve accuracy of feasibility
Develop measurements for the effectiveness of feasibility


・timeliness of completion of country allocation

・effectiveness of country allocation exercise

・ feedback from stakeholders


・Design and coordinate innovative solutions, including but not limited to digital and patient centric activities, through out study preparation, study conduct, in collaborate with responsible COJ leadership members and other stakeholders, including global parties, to ensure efficiency and productivity of trial conduct in Japan.


・innovative activities and impact on study conduct: time saved, cost saved; no of pat recruitment increased etc

・ stakeholder feedback

募集条件

  • ・Master degree required(preferably in Health Sciences, Healthcare, Nursing, etc.)with a minimum 7 years successful, progressive experience in the regulated pharmaceutical or healthcare industry;

    ・PhD degree preferred(preferably in Health Sciences, Healthcare, Nursing, etc.).




    ・Thorough understanding of all phases of drug development (I-IV);

    ・Understanding of PMDA regulations, ICH GCP and other applicable regulations / policies

    ・Understanding of regulations related to clinical trial

    ・Demonstrated experience leading and managing complexed projects

勤務開始日

  • 応相談

採用人数

  • 1

雇用形態

  • 正社員

勤務地

  • 東京

転勤有無

  • 当面なし

給与

  • 年齢経験により応相談