Location: Japan - Tokyo
Salary: 6000000 - 9000000 JPY
Job Function: Clinical Development
Reference: JO-180323-150114
Industry: Life Sciences & Healthcare
Sub-Industry: Pharmaceuticals

Company

◆グローバルランキング15位以内

◆福利厚生充実且つ、離職率も業界水準よりも低め

◆豊富なパイプラインとコンパウンドを持っており、今後もスペシャリティケア領域を中心に増

◆フレキシビリティの高い働き方を推奨し、定年後も再雇用実績あり

Job Description

Purposes of the job are,

  • To facilitate/support planning and execution of the company sponsored clinical studies, ensuring alignment of affiliate Development TA and Development Operations
  • To generate documents with high medical/scientific quality relevant to clinical studies and reporting to health authority

Key activities include,

Clinical Development

  • Ensure alignment of affiliate development strategy, study design and execution between Affiliate Development TA and Affiliate Development Operations/external partners
  • Contribute to the design of the protocol, engaging external experts
  • Communicate relevant local medical environment
  • Assist DFM in identifying qualified investigators/study sites
  • Support Clinical Development Operations activities.
  • Support CRA in conducting Site Engagement and Site Evaluation visits, and support remote site evaluation and central monitoring set up.
  • Develop and execute study-specific Site Relationship Management Plan for investigators to improve company and investigator relationship, including the below activities as required:
    • Enrollment support visit
    • Relationship issue management visit (Apology visit)
    • IRB support visit
    • Scientific interaction visit
  • Act as an interface between the study team and the Project Team
  • Coordinate providing scientific/medical content to address IRB/EC/national authority issues.
  • Assist Affiliate Development Operations in protocol interpretation
  • Scientifically review and edit documents relevant to global development and local clinical activities
  • Review translated version of documents relevant to global development and local clinical activities
  • Author/review/edit assigned part of CTD collaborating with Medical Director/Sr. Medical Advisor and Medical Writer
  • Support Affiliate Medical Directors/Sr. Medical Advisors in developing responses to queries from regulatory agencies
  • Organize advisory board meetings; data monitoring committees and steering/executive committees coordinating contracts, if necessary
  • Handle Consultancy Agreements and other Service Agreements with external experts for contracts owned by affiliate Development TA

Basic Qualifications

  • BA/BS/BSc
  • Three (3) or more years of clinical research experience and/or academic research experience including experience working on clinical trials
  • Plus > 2 year experience in study site-monitoring
  • Native level Japanese
  • Language proficiency in English (business discussions, reading, and writing)

Skills, Knowledge and Experience

  • Proficiency understanding the clinical strategy for products in the relevant therapeutic area (Oncology)
  • Extensive knowledge of Good Clinical Practices (GCP), HA regulations and guidelines, and international regulatory requirements/guidelines
  • Experience collaborating with external scientists
  • Experience conducting clinical trials in the relevant therapeutic area (Oncology)