The Global Study Associate (GSA) is a key member of the extended global study team, dedicated to supporting the delivery of clinical studies within BioPharmaceuticals Clinical Operations. The GSA ensures that clinical studies are executed efficiently, from set-up through maintenance, close-out, and archiving. By coordinating activities and maintaining quality and consistency, the GSA supports the Global Study Director (GSD), Global Study Associate Director (GSAD), and/or Global Study Manager (GSM). This role involves administration, systems management, and other delegated aspects of clinical study execution in compliance with applicable clinical trial regulations, AstraZeneca Standard Operating Procedures (SOPs), policies, best practices, and values.

Accountabilities

• Support GS(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 with International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs.
• Interact/collaborate with internal staff and external stakeholders in the collection of regulatory and other essential documents.
• 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. Proactively plan and collate the administrative appendices for the CSR.
• Initiate and maintain production 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 fulfill AstraZeneca compliance and meet regulatory authority needs.
• Support the GS(A)D with tracking, reconciliation, and follow-up of the study budget/payments in relevant systems.
• Contribute to application, coordination, supply, and tracking of study materials and equipment. Contribute to the collection of study supplies, if required, at the study close-out.
• Coordinate administrative tasks and logistic support throughout the conduct of the study, audits, and regulatory inspections, according to company policies and SOPs.
• Lead the practical arrangements, 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.

Essential Skills/Experience

• Education in medical or biological sciences or discipline associated with clinical research preferred
• Proven organizational and analytical skills
• Previous administrative training/experience
• Computer proficiency in day-to-day tasks
• Develop working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines
• Excellent verbal and written communication in English
• Demonstrate ability to work independently, as well as in a team environment
• Ability to prepare presentation materials
• Demonstrate professionalism and mutual respect
• Willingness and ability to train others on study administration procedures
• Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities

Desirable Skills/Experience

• Bachelor level education (or higher)
• Proven study admin/assistant or relevant experience on a study level
• Experience in clinical study lifecycle

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are driven by our passion for science. We are committed to making a difference by fusing data and technology with scientific innovations to achieve breakthroughs. Our inclusive environment encourages collaboration with academia, biotechs, and industry experts to create swift impacts on disease. We offer varied opportunities for lifelong learning and career development while working on projects that have never been done before.

Ready to make a difference? Apply now to join our team!

Location: Barcelona. Please apply with an english resume

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.