ESR

• Reports medical projects in all applicable databases (Evidence Connect, IMPACT).
• Instructs the investigators how to use ES2ROS (Externally Sponsored Scientific Research Operations System) database.
• Organises LREG(Local Review and Evaluation Group) meetings.
• Communicates with the GREG(Global Review and Evaluation Group) members.
• Communicates with CRO(Contract Research Organization)s/investigators regarding the project execution status.
• Prepares agreements with CROs/institutions/investigators/External Service Providers.
• Monitors the project execution milestones.
• Prepares applicable tracking reports for medical projects.
• Correspondence and telephone contacts with CROs, Investigator sites and AZ personnel on behalf of the MC  medical team members.
• Calculates and tracks project expenses and prepares the accrual report
• Manages study drug supplies to the investigator sites
• Raises and tracks study related payments and invoices.
• Ensures to record ESR documents onto ES2ROS database
• Assist in preparation of the study documents.
• Ensures accurate and timely reporting of Serious Adverse Events
• Assists in set up, maintenance and population of shared electronic study files and tracking systems (e.g. IMPACT, SSI (Study Specific Information) etc).
• Takes part in MC  ESR progress update meetings on an agenda driven basis.
• Contributes to compilation of specific application documents for Regulatory Authorities and EC/IRB(Ethics Committee/Institutional Review Board) submissions.
• Assists in activities associated with audits and regulatory inspections.

           EAP

• Ensures all applicable EAP local regulations are followed
• Ensures that work instructions are drafted in accordance with global EAP SOP to cover the local management of EAP
• Responsible for management of communications and submissions to regulatory authorities in EAP
• Responsible for handling and reporting all safety information in EAP

 

Date Posted

07-10월-2020

Closing Date

20-10월-2020

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.