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Clinical Research Associate

Clinical Research Associate

AstraZenecaTaiwan
20 天前
職務描述

Typical Accountabilities :

  • Ensures the processes for Study Delivery are executed through the development of study reports tools, facilitation of the study delivery system and maintenance of the system.
  • As an expert, ensures delivery of a centrally managed study management service across clinical studies from start up to reporting
  • Serve as main contact and works closely with the Document Management group until the Clinical Study Report is finalised
  • Initiates and maintains production of study documents, ensuring template and version compliance
  • Creates or imports clinical-regulatory documents into the Global Electronic Library according to the Global Document List
  • Interfaces with Data Management Centre or Data Management Enablement representatives to facilitate the delivery of study related documents
  • Manages and coordinates tracking of study materials and equipment
  • Monitors administrative tasks during the study process, audits and regulatory inspections, according to company policies
  • Acts as a technical owner within Patient Safety with a deep understanding of processes and internal regulations
  • Keeps own knowledge of best practices and new relevant developments up to date
  • Liaises with compliance team members to improve regulatory processes within the team
  • Identifies opportunities to improve the methodology and provide practical solutions for clinical development

Typical People Management Responsibility (direct / indirect reports) :

  • Approximate number of people managed in total (all levels) - None
  • What is the global remit? (how many countries will the role operate in?) :

  • Own country
  • Education, Qualifications, Skills and Experience :

  • Essential : Bachelor’s degree in relevant discipline; Experience of Study Management within a pharmaceutical or clinical background; Knowledge of relevant legislation and new developments in the area of Clinical Development and Study Management
  • Desirable : Advanced degree within the field; Professional certification; Understanding of multiple aspects within Study Management
  • Key Relationship to reach solutions :

  • Internal (to AZ or team) : Study management function; Other AstraZeneca employees
  • External (to AZ) : External service providers and regulatory bodies
  • Date Posted

    07-Apr-2025

    Closing Date

    05-Jul-2025

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    Clinical Research Associate • Taiwan