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

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.