Clinical Research Associate

• 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

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