At AstraZeneca, we're seeking a Global Study Associate to join our clinical study team. As a Global Study Associate, you will support the delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management. You will work closely with the Global Study Director, Global Study Associate Director, and/or Global Study Manager to coordinate activities, ensure quality and consistency. Your responsibilities will include initiating and leading the set-up of the electronic Trial Master File (eTMF), maintaining and closing the eTMF to ensure compliance with International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) and AstraZeneca Standard Operating Procedures (SOPs). You will also provide oversight for non-complex, non-critical path vendors, ensuring compliance with study requirements and established processes.
\nYou 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.
\nYou 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.
\nYou 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.
\nYou 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.
\nYou 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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\nAdditional Information
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\nAt Synopsys, we value diversity and inclusion, and consider all applicants for employment without regard to race, color, religion, national origin, gender, sexual orientation, age, military veteran status, or disability.
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