Clinical Operation Senior Manager - 製薬会社

Location: Tokyo, Japan
Job Type: Permanent
Salary: ¥8000000.00 - ¥17000000.00 per annum
Specialization: Life Science (Medical Devices / Pharmaceutical / Chemical / Healthcare / Agriculture / Livestock),
Sub Specialization: Clinical Trial / CRA / CRC,
Contact: Eureka Teramura
Reference: JO-2101-454050
about Eureka Teramura

※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.

[Company Description]
外資系製薬会社

  • 注目を集める次世代の技術を用いて、アンメット・メディカル・ニーズの高い領域向けの製品を手掛けています。
  • 次世代技術に関しては世界的リーダーの役割を担っています。
  • 開発技術に優れパイプラインが強いです。

[Responsibilities]

  • Manage project team activities; leveraging internal resources, and expertise knowledge
  • Manage aspects of CRO outsourcing, including : request for proposal development, CRO selection process, and the day to day study management activities of CROs.
  • The management through of CRO(s) ; Study sites including regulatory documents, CRO monitorvisit reports and site correspondence. Drug supply and use, enrollment of subjects, study timelines, financial information, Serious Adverse Events, performance metrics, data flow, etc.
  • Review of site ICFs
  • Involvement in discussion and help develop contingency/risk management plans for projects and assist Manager, Clinical Operations, Director of Clinical Operations in the preparation and execution of sound development strategies.
  • Create, track, and manage project budgets and timelines with an ability to provide comparison updates offinancial accruals versus projected budgets.
  • Interface with Regulatory Affairs, Finance, Program Management, Accounting, Supply Operations, Quality Assurance and Medical Affairs.
  • Review and approve vendor invoices for payment.
  • Ability to travel (no more than annual average of 25%).

[Requirements]

  • Bachelor's Degree is required. An advanced degree in scientific discipline, business/finance courses is preferred.
  • 3+ years of clinical project management experience gained within a CRO or Pharmaceutical Company working on Phase I - IV multinational clinical studies. Later stage clinical study experience a plus.
  • Regulatory and compliance knowledge, including Good Clinical Practices (GCPs)
  • Strong organizational skills and ability to deal with competing priorities, also strong reasoning and problem solving ability.
  • Excellent communication skills (written and verbal), along with presentation skills.
  • Knowledge of global clinical trial management. Ability to work with a team to assemble a plan yet execute on the details.
  • Protocol, ICF, CRF, CSR design and review.

[Employment Type]
Full time

[Salary]
8M-17M yen
※Experiences and skills will be considered

[Location]
Tokyo


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