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JAPANESE SPEAKING CLINICAL OPERATIONS SPECIALIST

Job title: JAPANESE SPEAKING CLINICAL OPERATIONS SPECIALIST
Contract type: Permanent
Location: Petaling Jaya, Petaling, Selangor
Specialisation:
Salary: RM5,500 - RM8,500
Start date: 28-09-2021
Reference: PR/146138
Contact details: Ailina Khalid
Contact email: Ailina.Khalid@jac-recruitment.com
Job published: September 10, 2021 15:38
JOB RESPONSIBILITIES
  • Contributes to all operational trial deliverables, according to timelines, budget, operational procedures, quality /compliance and performance standards.
  • Development of specific sections of the protocol and related documents; study tools, guidelines and training materials;
  • Implementing issue resolution plans and acting as point of contact for all site-related issues and procedural questions;
  • Assist with program level activities (e.g., tracking of program-related publications, development of clinical sections of regulatory documents etc.).
  • Managing interactions with relevant line functions including data management, drug supply management, clinical development and Company's Country Pharma Organizations;
  • Ensuring accurate handling of all study close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation.
  • Responsible for implementation of best practices and standards including sharing lessons learned.
  • Frequent internal company and external contacts. May represent organization on specific projects.
 
JOB REQUIREMENTS
  • Relevant educational background in life sciences/Healthcare (Ideally a Bachelor’s Degree or above in life sciences) or equivalent combination of education, training and experience.
  • Approximately 6 years’ of operational experience of clinical study execution in a pharmaceutical company or contract research organization.
  • Experience in finance: forecast, actuals, cost reconciliation, a plus.
  • Strong technical and organizational skills (Excel, MP). Details oriented.
  • Thorough knowledge of Good Clinical practice. Demonstrated ability to establish effective working relationship in a matrix and multicultural environment.
  • Demonstrated presentation and diplomacy skills.
  • Strong customer oriented approach.
  • Willingness to act accountably in project/study management.
  • Able to speak, read and write in Japanese to manage the counterparts in Japan
  • Travel internationally/domestically as required
 
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