ClinicalResearchAssociate

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;