Scientist, Clinical Trial Safety (fixed-term)

The Scientist, Clinical Trial Safety will work closely with the Senior Scientists, Senior Analysts and Associate Director, Scientists Clinical Trial Safety to support them in reviewing important and pre-specified medical (mainly safety) data in clinical trials as operated under the Research and Development (R&D) division of AstraZeneca. During the recruitment and maintenance phases of the clinical trial, he/she uses the Center’s data review tools to support review and query important clinical/safety data within the scope agreed with medical team and documented accordingly. The Scientist also supports preparation/facilitation of the meetings and management of study documents and trackers relevant to TRISARC activities. The roles are available for a fixed-term contract. Typical Accountabilities Supporting Senior Scientist, Senior Analyst and Associate Director, Scientist in their activities: • during study start-up activities by generating/managing the documents according to applicable procedures/best practices, set up/configuration of applicable tools, • review of patient-level clinical/safety data on an ongoing basis to ensure medical accuracy and completeness, coding consistency and generate applicable queries as needed to obtain information for appropriate medical assessment and case closure • schedule and facilitate different types of meetings • creating visualizations from applicable tools and prepare slides/reports/data as required • perform quality check of documents and file TRISARC documents in eTMF Other activities: • Take on tasks as assigned by the PTS/TRISARC LT • Provide input into non-drug project work including continuous improvement and development of procedures as needed • Update study statuses in tracker with studies per Therapeutic area upon request • Ensure TRISARC platforms (e.g. SharePoint) contains up-to-date information, documents, files. Coordinate updates, if needed • TRISARC mailboxes oversight • support preparation/participate in different type of study meetings (e.g. SSPR meetings) • Update/keep up to date TRISARC distribution lists on ongoing basis Education, Qualifications, Skills and Experience Essential • Educational degree (BSc/Msc/PhD) in Life Science or equivalent work experience in directly related fields (preferably medicine, pharmacy, veterinary, biotechnology, nurse, dentist) • Knowledge of ICH/GCP Guidelines • Knowledge of SAE reporting requirements • Strong attention-to-detail, analytical skills, and ability to concisely summarize large amounts of complex information • Ability to multi-task in a high-volume environment with shifting priorities • Excellent time management • Team player, able to work individually • Computer proficiency • Excellent knowledge of spoken and written English • Exhibit of AZ Values and Behaviours Desirable • Pharmacovigilance background, or experience working on clinical studies and/or study safety methodology • Clinical/medical background and practical experience providing a stable good knowledge in base for reviewing SAEs and other safety events • Understanding of the clinical study and drug development process in relation to study delivery operational activities • Understanding of clinical data flow • Programming experience Date Posted 06-lis-2023 Closing Date 10-lis-2023 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. AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process. You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.