Join our dynamic team as a Global Study Associate, a key player in the extended global study team supporting the delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management. This role is integral to ensuring our studies are delivered on time, within budget, and to the highest quality. As a GSA, you will support the Global Study Director (GSD), Global Study Associate Director (GSAD) and/or Global Study Manager (GSM) with coordinating activities, ensuring quality and consistency. Your role will involve administration & systems support and 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.
Accountabilities: As a Global Study Associate, you will be responsible for supporting GS(A)D and GSMs by completing delegated study work. You may work across many different studies and delivery models concurrently. Your tasks will include initiating and leading the set-up of the electronic Trial Master File (eTMF), maintaining and closing the eTMF to ensure compliance to International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs, interacting/collaborating with internal staff and external stakeholders in collection of regulatory and other essential documents, and much more. You will also 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.
Essential Skills/Experience: Education in medical or biological sciences or discipline associated with clinical research preferredProven organizational and analytical skillsPrevious administrative training/experienceComputer proficiency in day-to-day tasksDevelop 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 guidelinesExcellent verbal and written communication in EnglishDemonstrate ability to work independently, as well as in a team environmentAbility to prepare presentation materialsDemonstrate professionalism and mutual respectWillingness and ability to train others on study administration proceduresDisplay 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 levelExperience 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.
Why AstraZeneca? At AstraZeneca's Biopharmaceuticals R&D division, we are driven by our desire to understand and reveal new insights. We follow the science to explore, innovate, and unlock the power of what science can do. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference, fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. We are always listening and learning from people who live with the diseases our medicines treat, enabling us to better understand their needs and, ultimately, diagnose and design the right treatments to impact patients' lives.
Ready to embrace new and varied opportunities to develop and learn? Join us and be part of a team that makes a bigger impact on patients' lives. Apply now!
*Please apply with an English Resume
Date Posted 03-sept-2024
Closing Date 24-sept-2024
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.
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