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Clinical Operations Study Manager, Seoul, Korea

応募後で応募 求人ID R0036095 掲載日 06/15/2021 Location:Seoul, South Korea

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Job Description

  • Plan, set-up, monitor and coordinate Clinical Studies to the required standards of GCP, KGCP, and the company
  • Manage the CRO for outsourced clinical studies or PMS and track the progress of study to ensure it is conducted, recorded, and reported in accordance with the protocol, SOPs, ICH GCP, KGCP, applicable regulatory requirements and within the given budget and timeline
  • Responsible for the management of designated clinical trials  including investigator selection, analysis of potential patient recruitment, preparation of trial related documentation and organizing Ethics Committee submissions
  • Ensure procedures are in place for appropriate optimization  of patients into the Clinical Trial
  • Track and ensure timeline completion of trials and ensure trials are completed in accordance with local regulations and guidance
  • Support Investigator Initiated Research (IIR) in terms of drug management and contract related activities

[Requirements]

  • Educational Background/Major: Bachelor's or Master's degree in Biosciences, Nursing, Pharmaceutics, or equivalent field
  • Experience: 3 years of experience at Clinical Research in pharmaceutical industry
  • Mandatory Requirements:

                 1. Working at Seoul office
                 2. Computer skills including working knowledge of Microsoft Word, Excel
                 3. Strong written and verbal communication skills including good command of English language

  • Preferred Requirements: Protocol development, CSR writing or PMS periodic report writing/review experience would be preferred.

Type: 1 year Fixed-term (직계약직) 1년 계약, 1년 후 평가하여 연장계약 고려

Location: Songpa-gu, Seoul

Locations

Seoul, Korea

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time
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