Senior Scientist 1 - Clinical Trial Safety

Job Description

Job Title: Senior Scientist 1 - Clinical Trial Safety

Career level - D1

Introduction to role

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), we are dedicated to ensuring that patient data is complete and medically accurate, enabling study physicians and clinical scientists to interpret medical and safety data efficiently. 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. From setting up well-defined standards and eCRF modules to reviewing critical clinical/safety data during recruitment and maintenance phases, your role is pivotal in maintaining the integrity of our trials. You'll also prepare and facilitate meetings related to the review of study-level safety data, supporting study teams by writing patient narratives for qualifying events when applicable. Are you ready to take on this challenge?

Accountabilities

• Ensure consistent processes and efficient review of critical clinical/safety data
• Review patient-level clinical/safety data on an ongoing basis to ensure medical accuracy and completeness, coding consistency, and generate applicable queries as needed for appropriate medical assessment and case closure
• Prepare aggregated data visualization and facilitate meetings related to review of safety data on study level
• Contribute to study start-up activities according to the applicable process/procedures (e.g., input to the applicable documents, tools set up)
• Serve as a member of the Extended Study Team and report on TRISARC deliverables
• Work with study physicians and/or clinical/project scientists to support standardized high-level data review and medical evaluation
• Escalate urgent and critical medical cases to the study physician/medical scientist as appropriate
• Provide input into the process of setting automated patient narratives, if applicable
• Provide input to establishing the process for handwritten patient narratives, including guideline development and the quality control process if applicable
• Lead quality of own deliverables
• Take on tasks as assigned by the Directors, Associate Directors Clinical Trial Safety
• Provide input into non-drug project work including training activities, continuous improvement, and development of procedures as needed

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)
• Minimum eight years of experience working on clinical studies and/or study safety methodology
• Understanding of the clinical study and drug development process
• Knowledge of ICH/GCP Guidelines
• Knowledge of SAE reporting requirements
• Quality focus, analytical skills, and ability to concisely summarize large amounts of complex information
• Proven ability to prioritize and manage multiple tasks with conflicting deadlines
• Excellent time management
• Very good interpersonal and communication skills
• Team player, able to work individually
• Ability and willingness to work cross-functionally, e.g., with internal and external partners, on global studies, across different phases of drug development or different therapy areas
• Managing change and uncertainty for self
• Computer proficiency
• Excellent knowledge of spoken and written English
• Exhibit of AZ Values and Behaviours

Desirable Skills/Experience

• Experience using data review tools such as JReview, JMP Clinical, or Spotfire, EDC
• Ability to review/analyze and interpret aggregated data
• Ability to develop advanced computer skills to increase efficiency in day-to-day tasks
• Experience in medical writing and/or producing patient narratives

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 curiosity and courage, exploring what science can achieve. Our commitment to making a difference fuels our passion for innovation as we fuse data and technology with scientific breakthroughs. We embrace lifelong learning opportunities, empowering our team members to grow their careers while impacting patients' lives globally. With a diverse pipeline and cutting-edge resources, we are dedicated to delivering life-changing medicines.

Ready to make a difference? Apply now and join us in pushing the boundaries of science!

Date Posted

Closing Date

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.