Clinical Research Associate

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