Clinical Trial Safety Specialist

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 safety data flowing through the clinical trial environment in order to ensure patient data is complete and medically accurate thus allowing study physicians and scientists to interpret safety data efficiently.

The Clinical Trial Safety Specialist (CTSS) will be responsible for reviewing important and pre-specified safety data in early/late phase clinical trials as operated under the Research and Development (R&D) division of AstraZeneca. The CTSS will work closely with the core study team (including the following roles: Study Physician, Global Study Leader, Principal Clinical Study Data Manager, Statistician) to ensure well-defined standards are outlined during study setup, and appropriate eCRF modules and TRISARC Study Agreement (TSA) or Medical Oversight Plan (MOP) are in place. During the recruitment and maintenance phases of the clinical trial, he/she will use the Center’s data review tools (SENTRI, RAVE, REACT) to review and query important safety data such as Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI), Endpoints, Adverse Events leading to Discontinuation (DAEs) and other critical safety data agreed on study level. The CTSS will also prepare and facilitate Study Level Safety Review (SSLR) / Study Safety Periodic Review (SSPR)meetings which purpose is to monitor and identify potential safety signals . In some studies CTSS may support study teams via writing patient narratives for qualifying events (SAEs, AESIs, and DAEs).

Typical Accountabilities

• Ensure consistent processes and efficient review of critical safety data

• Responsible for handling of safety data – review for medical completeness, medical accuracy, and coding consistency

• Prepare and review queries to obtain critical or missing serious adverse events (SAE) information for appropriate medical assessment and case closure

• Review of patient-level AE/SAE study safety data on an ongoing basis to ensure medical accuracy and completeness and generate applicable queries as needed

• Prepare aggregated data visualization and facilitate Study Level safety Review meetings

• Contribute to study start-up activities such as the generation of TRISARC Study Agreement/ Medical Oversight Plan, Study Level Safety Review plan and input to the Safety Management Plan, relevant eCRF modules, Trial Integrity Plan and safety sections of the Clinical Study Protocol

• 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

• During the course of the clinical trial, author manual patient narratives for SAEs, AESIs, and AEs that lead to discontinuation of study drug (DAEs) when required. After Database Lock, finalize manual patient narratives and ensure they are submission-ready if applicable

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

• Work with the study physician and/or clinical scientist to support high-level data review and medical evaluation

• Escalate urgent and critical medical cases to the study physician as appropriate

• Take on tasks as assigned by the Associate Director Trial Safety Review Center

• Provide input into non-drug project work including training activities, continuous improvement and development of procedures as needed