You will interact and collaborate with internal staff and external stakeholders in the collection of regulatory and other essential documents. You will contribute to electronic applications/submissions in the regulatory information management system by creating and managing clinical regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory authorities. You will proactively plan and collate the administrative appendices for the CSR. You will initiate, maintain, and/or support the creation of study documents, ensuring template and version compliance per study-specific requirements.

You will set up, populate, and accurately maintain information in AstraZeneca tracking and communication tools and support team members in the usage of these tools. You will support the set-up, maintenance, and close-out of Clinical Trial Transparency (CTT) activity in PharmaCM, coordinating with relevant stakeholders to fulfill AstraZeneca compliance and meet the regulatory authority needs. You will support the Global Study Director 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.

You will contribute to application, coordination, supply, and tracking of study materials and equipment. You will contribute to the collection of study supplies, if required, at the study close-out. You will coordinate and provide oversight of administrative tasks and logistical support throughout the conduct of the study, audits, and regulatory inspections, according to company policies and SOPs.

You will lead the coordination and contribute to the preparation of internal and external meetings, such as study team meetings, committee meetings, monitor meetings, Investigator meetings, and virtual meetings. You will liaise with internal and external participants and/or vendors. You will prepare, contribute, and distribute presentation material for meetings, newsletters, and websites.

You will work on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with your manager. You will perform other duties as assigned and within the scope of your role.

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