- 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
