Scientist,Clinical Trial Safety

Job Title: Scientist, Clinical Trial Safety

Global Career Level: C

Introduction to role

Are you ready to make a difference in the world of clinical trials? At AstraZeneca, the Trial Safety Review Center (TRISARC) is at the forefront of ensuring patient safety and data accuracy. The primary remit of the TRISARC is to review large amounts of clinical (mainly safety) data flowing through the clinical trial environment in order to ensure patient data is complete and medically accurate thus allowing study physicians and/or clinical(project) scientists to interpret medical/safety data efficiently. 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.

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

Essential Skills/Experience

• 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 Skills/Experience

• Pharmacovigilance background or experience working on clinical studies and/or study safety methodology
• Clinical/medical background with practical experience in reviewing SAEs and other safety events
• Understanding of the clinical study and drug development process
• Understanding of clinical data flow
• Programming experience

Key relationships to reach solutions

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 and innovation. Our commitment to exploring new frontiers in healthcare allows us to tackle some of the world's most complex diseases. By fusing data and technology with scientific breakthroughs, we aim to make a significant impact on patients' lives globally. Our inclusive environment encourages collaboration across diverse teams, fostering an atmosphere where curiosity thrives. With opportunities for lifelong learning and career development, AstraZeneca is where you can truly make a difference.

Ready to embark on this exciting journey with us? Apply now to join our team and help shape the future of healthcare!