Clinical Research Associate

Alexion Pharmaceuticals

  • Da-an, Taipei City
  • Permanent
  • Full-time
  • 1 month ago
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 28-Jul-2025Closing Date 27-Oct-2025Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.

Alexion Pharmaceuticals