Clinical Data Manager

日本 外資系企業 8,000,000¥ - 10,000,000¥ 外資系企業
  • Work for an Expanding European Pharmaceutical Company
  • Drive and Coordinate Clinical Data Management Activities in Japan

企業情報

  • European pharmaceutical company, with expanding development pipeline in internal medicine

職務内容

  • Manage clinical data management for international trials in phase II - IV in close corporation with other clinical team members.
  • Day-to-day co-ordination with stakeholders and oversee the delivery of essential documents to Trial Master File and compile these documents
  • Quality control of pre-defined documents in the Trial Master File and sending Trial Master documents to FCA
    Collection, compilation and quality control of documents to clinical trial report appendices
  • Handling of trial documents in CTMS
  • Co-ordination of insurance documents
  • Being a super user of the electronic document management system; and contribute to eCTD projects
  • Production, review and update of pre-defined section in the monitor's manual and training stakeholders in documentation handling
  • Handling and distribution of SUSARs
  • Appropriate compliance with GCP, SOPs, guidelines and regulatory requirements
  • Develop the document handling processes in line with requirements and technical possibilities
  • Experience with electronic document management systems
  • Experience from archiving electronic and paper clinical documents
  • Previous experience from the pharmaceutical industry
  • Ideally previous experience with clinical trial documentation
  • Ideally previous experience with multi-country and multi-centre studies
  • Experienced user of the Microsoft Office package and in particular Excel
  • Fluency in English, both spoken and written

理想の人材

  • Sufficient level of English and Japanese to be able to communicate fluently with other functions
  • Experience in the following areas
  • Contributing to project/trial team as a team member
  • Preparation or review specifications and/or programs
  • Oversight of CROs/ IT Vendors
  • Communication with PMDA, especially in eData submission
  • Regular meetings with other regions' colleagues
  • Logical thinking and problem solving skill is expected
  • Open mindset for diversity and inclusion

条件・待遇

  • Expand your career as a clinical data management expert
コンタクト
Ed Marsden
求人番号
4194209
電話
+813 6832 8981

求人情報

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
4194209
企業タイプ