Global Study Associate
hace 2 semanas
**Location**:Barcelona (On-site). We require 3 days working from the office and 2 days working from home.
**Type of Contract**: 1 year Fixed term contract.
The Global Study Associate (GSA) is a vital member of the extended global study team, supporting the delivery of clinical studies within Late Development Oncology (LDO) to time, cost, and quality standards. From Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, and development of Clinical Study Report (CSR) to study archiving, the GSA plays a crucial role. You will support the Global Study Director (GSD), Global Study Associate Director (GSAD), and Global Study Managers (GSMs) in various aspects of clinical study execution, adhering to the Study Team Operating Model (STOM), AZ Project Management Framework, current clinical trial regulations (e.g., ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies, and best practices.
**Accountabilities**
- Support Global Study Director (GSD) / Global Study Associate Director (GSAD) and Global Study Managers (GSMs) by completing delegated study work.
- 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 Site Management & Monitoring, other internal staff, and external vendors in the collection of regulatory and other essential documents.
- 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 (e.g., IMPACT, SharePoint, BOX if used, MS Teams, and study team shared mailbox) 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 GSD/GSAD with tracking, reconciliation, and follow-up of the study budget/payments in relevant systems (e.g., iBUY, FIND).
- 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
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, you will work with diverse minds united by a shared passion to learn, grow, and discover. Join our unrivalled scientific community that fuses academia and industry. We work seamlessly together, playing to each other's strengths while celebrating successes. Embrace this opportunity to build a meaningful career within a diverse community that includes female leaders in 45% of senior roles. With 475 pre-clinical collaborations across 26 countries worldwide and a collaborative research initiative uniting seven of the world's foremost oncology medical centres, we are dedicated to expediting research in some of the hardest-to-treat cancers.
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