Clinical Trial Manager - up to 15m JPY

Japan Permanent Foreign Multinational
  • Partner with Drug Companies to Bring New Oncology Therapies to Market
  • Improve Cancer Patient Outcomes through Early Diagnosis and Monitoring

About Our Client

  • Advanced oncology focused IVD company
  • The company develops blood tests for early detection in high-risk populations and monitoring in cancer survivors and provide advanced cancer patients with the information necessary to obtain the right treatment


  • On the commercial side, they also support drug companies to get new therapies to market faster through utilizing diagnostics in the clinical trial phase as a precise measure of efficacy


  • In Japan the company is still in growth phase, but have received large investment from major technology company to support in these efforts

Job Description

  • Policy and protocol planning for post-marketing surveillance

  • Develop research policy and plan, and estimate research budget for assigned drugs and indications based on agreement with relevant parties to obtain global approval


  • GAP analysis and evidence generation (non-regulatory)


  • Actively participate in GAP analysis and research planning as a partner of TA in the assigned disease area


  • Publication to be responsible for the preparation and publication of the manuscript as an author in the assigned project


  • Comply with industry and company rules and ensure that all employees are aware of them (including education)


  • Propose the most effective solution to inquiries from PMDA regarding post-marketing surveillance for which you are in charge, and negotiate with PMDA through internal agreement


  • Negotiate with PMDA through internal agreement
  • Share and communicate information appropriately with all internal stakeholders related to the project to ensure that the study in charge proceeds as planned

The Successful Applicant

  • Over 5 years of clinical trial work experience in the pharmaceutical / CRO industry, ideally in the oncology space
  • Work experience related to quality control or quality assurance
  • Related to new drug approval (GCP compliance survey) or reexamination compliance survey (GPSP compliance survey)
  • Problem-solving skills
  • Assertive communication
  • Knowledge of related regulations (ICH-GCP, J-GCP, GPSP, etc.)
  • TOEIC 700 points or more (English document preparation, meetings, email correspondence available)
  • Have the ability to properly identify the gap between the current state of the organization and what it should be, and deal with that gap.

What's on Offer

  • Work in an international environment, clear career development opportunities, contribute to global clinical studies
  • Contributed to a rapidly growing industry with potential to have huge impact on cancer patients' lives globally
Contact
Ed Marsden
Quote job ref
4219837
Phone number
+813 6832 8981

Job summary

Function
Specialisation
Location
Job Type
Consultant name
Ed Marsden
Consultant phone
+813 6832 8981
Job Reference
4219837
Company Type