Clinical Scientist - Haemotology

東京23区 外資系企業 13,000,000¥ - 15,000,000¥ 外資系企業
  • Work for industry leading oncology focused biopharmaceutical company
  • Contribute to development of innovative new cell therapies

企業情報

  • Industry leading multinational pharmaceutical company with high expertise in oncology, immunology, cardiovascular and metabolic diseases

職務内容

  • Conduct literature review

  • Submit clinical documents to TMF

  • Develop site and CRA training materials and present these at SIVs and Investigator meetings

  • Review clinical narratives

  • Monitor clinical data for specific trends; provide trends and escalate questions to Japan Clinical Trial Physician

  • Develop Data Review Plan in collaboration with Data Management

  • Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming

  • Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, HA, EC, IRB responses and contribute to regulatory submission.)

理想の人材

  • Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred).

  • Knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations

  • Ability to understand assigned protocol(s) and their requirements

  • Basic knowledge skills to support program-specific data review and trend identification

  • Intermediate medical writing skills and medical terminology

  • Basic planning/project management skills (develop short range plans that are realistic and effective)

  • Experience in Industry in a Clinical research or relevant environment

  • Detail-oriented with commitment to quality

  • Basic knowledge of disease area, compound, current clinical landscape

  • Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees

  • Intermediate critical thinking and problem-solving skills

  • Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)

  • Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)

  • A certain level of spoken and written English for business is required

条件・待遇

  • Opportunity to expand your career in the field of drug development
  • Contribute to approval of new therapies in oncology / haematology field
コンタクト
Ed Marsden
求人番号
4194701
電話
+813 6832 8981

求人情報

職種
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
4194701
企業タイプ