Global Study Associate

The   G lobal Study Associate   is a member of   the   global study team supporting delivery of clinical studies   within   BioPharmaceuticals   Clinical   Operations, Study Management   to   time,   cost   and quality .     The   GSA   supports delivery of global clinical studies from study set-up through maintenance,   close-out   and study archiving. The GSA supports 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 G S(A)D and   GSMs by completing delegated study work . May work across many different studies and delivery models concurrently.   • Initiate and lead the set-up of the electronic Trial Master File (eTMF). Maintain and close the eTMF to ensure compliance to International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs .   • Provide oversight for non-complex, non-critical path vendors, ensuring compliance with study requirements and established processes .   • Interact/collaborate with internal staff and external   stakeholders   in collection of regulatory and other essential documents .   • Contribute to electronic applications/submissions in   r egulatory   i nformation   m anagement   system by   creating and managing clinical   regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory authorities. Proactively plan and collate the administrative appendices for the CSR .   • Initiate ,   maintain   and/or support the   creation   of study documents, ensuring template and version compliance per study specific requirements .   • Set-up, populate and accurately   maintain   information in AstraZeneca tracking and communication tools and support team members in the usage of these tools .   • Support the set-up,   maintenance   and close-out of Clinical Trial Transparency (CTT) activity in   PharmaCM , coordinating with relevant stakeholders to fulfil AstraZeneca compliance and meet the regulatory authority needs .   • Support the GS ( A ) D with tracking,   reconciliation   and follow-up of the study budget/payments in   relevant systems ,   including   the   creation and maintenance of purchase orders, running invoice and payment reports .   • Contribute to application, coordination, supply and tracking of study materials and equipment.     • Contribute to collection of study supplies, if   required , at the study close-out .   • Coordinate   and provide oversight   of   administrative tasks and logistic al   support   throughout the conduct of the study,   audits   and regulatory inspections, according to company policies and SOPs .   • Lead the   coordination and   contribute to the preparation of internal and external meetings   e.g.,   study team meetings, committee meetings,   monitor   meetings, Investigator   meetings   and virtual meetings. Liaise with internal and external participants and/or vendors .     • Prepare,   contribute   and distribute presentation material for meetings,   newsletters   and websites .   • Work on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager .   • Other duties as assigned and within scope of role.    Education, Qualifications,   Skills   and Experience   Essential   • Education in medical or biological sciences or