Why choose AstraZeneca Spain?

AstraZeneca Spain is a rising force in our global business. With headquarters in Madrid and our global hub in Barcelona, we’ve become an important international centre of excellence in the fight against critical disease. Boasting vibrant universities and business schools, the Barcelona ecosystem is a place where scientists can thrive. We attract a diverse workforce from across the globe, shining a beacon for innovation in a country that’s committed to clinical development.

We invite you to bring your talents to Barcelona where our respiratory medicine R&D and Global Marketing centre offers opportunities in R&D, IT, Commercial and HR. Or join us in Madrid and shape our growth in our BUs (Respiratory, Oncology & CVRM ), and a range of Corporate functions. Additionally, you can find sales roles throughout the country. Together, we’re contributing to a world-leading pipeline of therapeutics and delivering life-changing medicines to patients.

Who do we look for?

Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca Spain, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. Alongside technical expertise, colleagues have the resilience, energy and collaborative mindset to change lanes, work with different teams and start projects from scratch.

Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Madrid or Barcelona, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day.

Diverse collaborators

This is a speak-up culture that values collaboration. You’ll proactively bring your unique perspectives, experiences and skills to the table and seek the same from others. With our international team composition and the need for fast-paced collaboration, you’ll always be building new connections with colleagues.

Cutting-edge innovators

When you join us, you’ll be part of a team that embraces digital technology and data to transform the way we work and the work we do. Every day, you’ll help make history, empowered to ignite your creativity and build something enduring.

Resilient trailblazers

Here, the answers aren’t always available. So, you’ll need to bring a fearless, self-starter mindset to navigate uncharted territories. You’ll harness your ceaseless energy to discover and make the necessary connections with colleagues to shape the future and achieve maximum impact.

Agile movers

Seize ownership and excel with autonomy to enjoy the constant rush of ground-breaking discovery. Your ability to anticipate sudden shifts and adapt swiftly will prove critical as you make your mark in an environment that rewards initiative and resilience.

The Global 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 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 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 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. 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 logistical 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 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

• Bachelor level education (or higher)

• Proven study admin/assistant or relevant experience on a study level

• Experience in clinical study lifecycle

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.