• Drives clinical study start-up, execution, close-out and reporting
• Collects reviews and tracks regulatory and other relevant documents. Interface with Investigators, CROs and Marketing Companies during the collection process to support effective delivery of a study and its regulatory documents. Serve as main contact and work closely with Document Management group until finalization of the Clinical Study Report (CSR)
• Initiates and leads the set-up of the Study Master File (SMF) including tracking of documents. Maintain and close the SMF ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance
• Initiates and maintains production of study documents, ensuring template and version compliance
• Creates and/or imports clinical-regulatory documents into the Global Electronic Library (GEL) according to the Global Document List (GDL) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents to support publishing in GEL
• Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e. Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities
• Leads administrative appendices for the CSR
• Interfaces with Data Management Centre and/or Data Management Enablement representatives to facilitate the delivery of study related documents
• Provides input into non-drug project work including training activities and development of procedures as needed
• Monitors the set-up and maintenance of information in AstraZeneca tracking and communication tools (e.g. IMPACT, Clinical Partners Portal and eRoom) and support others in the usage of these systems
• Manages and coordinates tracking of study materials and equipment
• Monitors administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs
• Leads the practical arrangements and contribute to the preparation of internal and external meetings e.g. study team meetings, monitor meetings, Investigator meetings. Liaise with internal and external participants and/or vendors
• Prepares, contributes to and distributes presentation material for meetings, newsletters and web-sites
• Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration

Qualification

•  Bachelor degree or higher, preferably with a pharmacy, nursing or medical related field
•  At least 2 years experience in clinical trial monitoring
•  Fluent knowledge of spoken and written English.
• Good ability to learn and to adapt to work with IT systems
• Ability to travel nationally as required. 

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.