Senior Scientist 1 - Clinical Trial Safety

@ AstraZeneca

Senior Scientist 1 - Clinical Trial Safety

Are you ready to dive into the world of clinical trial safety and make a real impact? At AstraZeneca's Trial Safety Review Center (TRISARC), you will ensure that patient data is complete and medically accurate, helping study physicians and clinical scientists interpret medical and safety data efficiently.

Role Overview

As a Senior Scientist I in Clinical Trial Safety, you will collaborate closely with core and extended study teams throughout every stage of the clinical trial. Your tasks include setting up well-defined standards and eCRF modules, reviewing critical clinical and safety data during recruitment and maintenance phases, and preparing data visualizations and meeting presentations.

Accountabilities

• Review patient-level clinical/safety data ensuring medical accuracy and completeness.
• Generate applicable queries for medical assessment and case closure.
• Prepare aggregated data visualizations and facilitate review meetings.
• Support study start-up activities and contribute to the setup process.
• Collaborate with study physicians to support standardized high-level data review.
• Provide input for automated and handwritten patient narratives.
• Ensure quality of deliverables and take on additional tasks as assigned.

Essential Skills/Experience

A degree in Life Science (BSc/MSc/PhD) or equivalent experience is required along with at least two years of clinical study or safety methodology experience. Candidates must understand the clinical study and drug development process, ICH/GCP guidelines, and SAE reporting requirements. Quality focus, excellent communication, and teamwork skills are essential.

Desirable Skills/Experience

• Experience with data review tools (JReview, JMP Clinical, Spotfire, EDC).
• Ability to analyze aggregated data and produce patient narratives.
• Advanced computer skills for day-to-day tasks efficiency.
• Experience in medical writing.

Work Environment

This role requires in-person work a minimum of three days per week, balanced with flexibility. You will be part of a diverse, dynamic team passionate about pushing scientific boundaries and making a meaningful difference in patients' lives.

Key skills/competency

Senior Scientist 1 - Clinical Trial Safety: clinical trials, safety data, eCRF, data visualization, patient narratives, ICH/GCP, SAE reporting, regulatory, quality control, cross-functional collaboration.