AstraZeneca Pharmaceuticals LP Clinical Trial Safety Analyst (TRISARC) in Warsaw, Poland
Development Operations within Biopharmaceutical R&D is accountable for the delivery of clinical studies.
The Global Center for Clinical Trial Safety Data Review (TRISARC) is a department in the Biopharmaceutical R&D Development Operations / Development Operations Quality Training and Risk Management 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 Analyst (CTSA) in Trial Safety Review Centre (TRISARC) will be responsible for tools set-up, scripting, and data analytics tasks for the Global Center for Clinical Trial Safety Data Review. The CTSA will work closely with the Clinical Trial Safety Specialist to ensure safety data deliverables are executed per pre-defined plans. The CTSA will be adept at utilizing the Center’s Data Review tool of choice and should possess programming experience.
Ensure the Data Review tool is fit for purpose through appropriate set-up according to agreed Best Practice procedures – to allow for handling of safety data and review for medical completeness and medical accuracy
Generate high quality Data Review reports that are aligned for TRISARC members and the Global Therapeutic Areas
Support the TRISARC team in the review of cumulative AE/SAE study safety data on an ongoing basis to ensure medical accuracy and completeness and generate applicable queries as needed
Support and assist Study Physicians and Scientists both locally and globally with Level 2 (querying) and level 3 (evaluation and interpretation) data review – including, data visualization and compilation of aggregate data views or complex datasets.
Work with and manipulate data outputs (i.e. generate reports, macros/scripts) from multiple sources such as the clinical database, external labs, ECG providers, and other safety vendors as appropriate.
Take on ad-hoc tasks as assigned by the Associate Director Clinical Trial Safety
Provide input into non-drug project work including training activities, continuous improvement, and development of procedures as needed
Work closely with IT and R&D Information functions to align on tool maintenance and tool improvement; provide customer feedback from the end user (TRISARC Safety Specialists, Study Physicians, Clinical Scientists)
Assist with document flow and tools maintenance to support authoring of handwritten patient narratives; maintain tracking and essential communication within narrative production cycle
Education, Qualifications, Skills and Experience
University degree in related discipline
Minimum one year of experience working on clinical studies
Proven organizational and analytical skills
Understanding of the clinical study and drug development process and GCP/ICH guidelines in relation to study delivery operational activities
Knowledge of SAE reporting requirements
Proven ability to prioritize and manage multiple tasks with conflicting deadlines
Ability to work independently, as well as in a team environment
Computer proficiency including Microsoft Outlook and Excel
Excellent knowledge of spoken and written English
Exhibit of AZ Values and Behaviours
Relevant industry or health care experience
Demonstrates ability and willingness to work and lead cross-functionally, e.g. with internal and external partners, on global studies, across different phases of drug development or different therapy areas
Good understanding of clinical data flow
Strong attention-to-detail, analytical skills, and ability to concisely summarize large amounts of complex information
Ability to develop advanced computer skills to increase efficiency in day to day tasks
Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities
Experience using data review tools such as JReview, JMP Clinical, or Spotfire