ABOUT DEPARTMENT
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.
JOB ROLE
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.
TYPICAL 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
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 EXPERIENCE/SKILLS
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
Pharmacovigilance background, or experience working on clinical studies and/or study safety methodology
Clinical/medical background and practical experience providing a stable good knowledge in base for reviewing SAEs and other safety events
Understanding of the clinical study and drug development process in relation to study delivery operational activities
Uderstanding of clinical data flow
Programming experience
