Global Study Associate, Haematology

at  AstraZeneca

JOB SUMMARY

The Global Study Associate (GSA) supports delivery of global clinical studies from study set-up through maintenance, close-out and study archiving. You will support the Global Study Director (GSD), Global Study Associate Director (GSAD) and/or Global Study Manager (GSM) with coordinating activities, ensuring quality and consistency. The GSA supports with administration & systems and with other delegated aspects of clinical study execution in accordance with applicable clinical trial regulations (ex. ICH-GCP), AstraZeneca (AZ) Standard Operating Procedures (SOPs), AZ policies & best practices and AZ values & behaviours.

TYPICAL ACCOUNTABILITIES

• Support the GSD, GSAD and/or GSM by completing delegated study work as required. May work across many different studies and delivery models concurrently.
• Set-up, maintain and close the Trial Master File (TMF) as delegated by the GSD/GSAD. Ensure compliance to ICH-GCP and AZ SOPs.
• Interact/collaborate with internal and external partners in collection of regulatory and other documents/information.
• Handle the collection, reviewing, and tracking of relevant study documents in the TMF.
• Support production of study documents (as delegated), ensuring template and version compliance per study-specific requirements.
• Contribute to and distribute meeting material and other varied forms of communication.
• Contribute to electronic applications/submissions in ANGEL by creating and managing clinical-regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory authorities. Collate the administrative appendices for the Clinical Study Report.
• Set-up, populate and accurately maintain information in AZ tracking and communication tools (e.g. CTMS, SharePoint, MS Teams etc.) and support team members in the usage of these tools.

Please refer the Job description for details