Evidence Delivery Lead - 製薬会社

お問合せ Hidetoshi Sato
JOB ID JO-2109-463529

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

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[Position] Evidence Delivery Lead
[Location] 東京都 or 大阪府/在宅勤務制度あり
[Salary] 10〜16 million JPY ※Experiences and skills will be considered
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[Company Description]
外資系製薬会社

  • 世界100カ国以上で事業を展開し、社員50,000人の規模を誇る世界トップクラスの企業

[Responsibilities]
Evidence Delivery Lead (EDL) affiliates to Japan Evidence & Observational Research (EOR). EDL is a project leadership role in delivering our sponsored scientific studies and medical evidence generation to support our business and value claims, in line with strategy, governance processes and standard operation procedures.

Business Planning & Control

  • EDL supports Therapeutic Area Medical Affairs(TAMA) Team in organizing the cross functional strategic evidence planning workshops for quality evidence plans
  • EDL supports Business Planning Process as EOR window person for each TA team so that the Evidence Generation costs are forecasted as per the agreed evidence plans
  • EDL contribute to ensure that Evidence plans/study concepts are scientifically and methodologically feasible to address research questions, feasible to time, cost, quality and capacity
  • EDL works with EDOS in planning and controlling to track and manage the progress of Evidence Generation programs as per the agreed business plans

Company's Sponsored Studies Delivery

  • EDL ensures the operational/methodological feasibility of the study concepts/plans to initiate
  • EDL is responsible to select the best external service providers (ESPs) as per the project requirements and manage the performance throughout the study
  • EDL leads delivery of all components of a scientific study to time, quality, budget, project standards, company quality standards, and scientific requirements during the course of the study from SDC development through database lock, analysis, reporting and study closeout activities
  • EDL is the cross-functional study team leader ensuring that studies are delivered by leveraging all available best practice, members' expertise and relevant resources across company to address research questions
  • EDL contributes to uplift RWE capabilities of individuals involved in the Evidence Generation projects

[Requirements]

  • Master degree in a scientific discipline
  • > 3years Trial Manager experience
  • Manage CROs for clinical studies
  • Lead protocol development
  • Design study outline
  • Drive data management activities
  • Lead data analysis discussions and result-interpretation discussions
  • Execute study reporting activities
  • Clinical Study Execution
  • External Service Provider (i.e. CROs) Management
  • Leadership & Communication
  • Project Management
  • Read/write scientific documents including economic research in English/Japanese
  • Practical English communication skill with TOEIC 800
  • Make a Japanese presentation leading and facilitating the HTA discussions in the global meetings
  • Cross-functional Stakeholder management skill

[Preferred Knowledge, Skills and Abilities]

  • PhD in a scientific discipline or MD or MPH
  • Researches using statistics and epidemiology
  • Working both in R&D and Medical (>3 years each)
  • Experience of real world studies or post launch studies
  • Line management experience
  • Clinical Project Leader experience
  • Working experience in global organization / teams
  • Study Design, Statistics and Epidemiology
  • Medical writing & Scientific Publication
  • Demonstrated English communication skills in Global Team or outside Japan


Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Reference: JO-2109-463529
#LI-REMOTE
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Project Management