Senior Scientist I, Clinical Trial Safety (permanent/secondment)

The Trial Safety Review Center (TRISARC) is a department in the Research and Development function of AstraZeneca. 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 Senior Scientist I, Clinical Trial Safety works closely with the core and extended study teams at every stage of the clinical trial. During study set up he/she ensures well-defined standards are outlined and appropriate eCRF modules and Safety Monitoring agreements are in place. During the recruitment and maintenance phases of the clinical trial, he/she uses the Center’s data review tool to review and query important clinical/safety data within the scope agreed with Medical team and documented accordingly. The Senior Scientist I also prepares and facilitates meeting related to review of Study Level safety data. He/she supports study teams via writing patient narratives for qualifying events, if applicable.

Responsibilities:

• Ensure consistent processes and efficient review of critical clinical/safety data

• 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

• 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 (ex. input to the applicable documents, tools set up)

• Serve as a member of the Extended Study Team and report on TRISARC deliverables

• Work with the 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.

Requirements:

Essential

• Educational degree (BSc/Msc/PhD) in Life Science or equivalent work experience in directly related fields (preferably medicine, pharmacy, veterinary, biotechnology, nurse, dentist)
• Minimum two 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

• Experience using data review tools such as JReview, JMP Clinical, or Spotfire, EDC
• Ability 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

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 authorisation and employment eligibility verification requirements.