AstraZeneca Pharmaceuticals LP Clinical Development Associate in Shanghai, China

  • Participate in the coordination of and contribute to operational (activities to ensure quality and consistency of Operations deliverables to time, cost, and quality objectives from Study Specifications (SS) through study close-out activities and Clinical Study Report (CSR).

  • Contribute to clinical study start-up, execution, close-out and reporting

  • Collect, review and track regulatory and other relevant documents. Interface with Investigators, Strategic Partners, Site Management & Monitoring and internal staff during the collection process to support effective delivery of a study and its regulatory documents through finalization of the Clinical Study Report (CSR)

  • Initiate and lead the set-up of the electronic Trial Master File (eTMF) including tracking of documents. Maintain and close the eTMF ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance

  • Initiate and maintain production of study documents, ensuring template and version compliance

  • Create and/or import clinical-regulatory documents into the Global Electronic Library (GEL) according to the Global Document List (GDL) and maintain documents according to current process ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents to support publishing in GEL

  • Contribute 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

  • Plan and proactively collate the administrative appendices for the CSR

  • Interface with Data Management Centre and/or Data Management Enablement representatives to facilitate the delivery of study related documents

  • Provide input into non-drug project work including training activities and development of procedures as needed

  • Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. IMPACT, ISSIS, Clinical Partners Portal and SharePoint) and support others in the usage of these systems

  • Manage and contribute to coordination and tracking of study materials and equipment

  • Coordinate administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs

  • Lead the practical arrangements and contribute to the preparation of internal and external meetings e.g. study team meetings, ISS review meetings, monitor meetings, Investigator meetings. Liase with internal and external participants and/or vendors

  • Prepare, contribute to and distribute presentation material for meetings, newsletters and web-sites