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AstraZeneca

Analyst, Clinical Trial Safety (12 months secondment/fixed term contract)

AstraZeneca
Poland · Full-time · Entry
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 medical (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 clinical/project scientists to interpret safety data efficiently.

The Analyst, Clinical Trial Safety is responsible for support of tools set-up & maintenance, scripting, data analysis tasks for the Clinical Trial Safety. The Analyst works closely with all level Analysts & Scientists, Clinical Trial Safety to ensure safety data deliverables are executed per pre-defined plans and up to quality and timelines. The Analyst supports preparation/facilitation of the meetings and management of study documents and trackers relevant to TRISARC activities.

Responsibilities:


  • Supporting Senior Analyst and Associate Director, Analyst in their activities:
  • Data Review tool set-up, maintenance and close-out of study according to agreed Best Practice procedures – to allow for handling of safety data and review for medical completeness and medical accuracy
  • Generation of high quality reports that are aligned for TRISARC members and the Global Therapeutic Areas
  • Work with 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.
  • Generate summary reports,
  • Analyze and visualize clinical data from different sources including but not limited to eCRF, external lab, clinical databases.
  • tool maintenance and tool improvement; provide customer feedback from the end user (TRISARC Safety Scientists, Study Physicians, Clinical Scientists)
  • data analysis and visualization
  • Take on ad-hoc tasks as assigned by the TRISARC Leadership team members
  • Input into non-drug project work including training activities, continuous improvement, and development of procedures as needed
  • Perform quality check of documents and file TRISARC documents in eTMF
  • Update study statuses in tracker
  • Ensure TRISARC platforms (e.g. SharePoint) contains up-to-date information, documents, files. Coordinate updates, if needed
  • Support preparation/participate in different type of meetings


Requirements:

Eseential


  • University degree in related discipline
  • Analytical skills
  • Experience in data analysis
  • Advanced computer skills (Microsoft Outlook, Excel and Microsoft Power Platform)
  • Proven organizational and analytical skills
  • Proven ability to prioritize and manage multiple tasks with conflicting deadlines
  • Ability to work independently, as well as in a team environment
  • Independently designing and planning own work
  • Managing change and uncertainty for self
  • Excellent knowledge of spoken and written English
  • Exhibit of AZ Values and Behaviours


Desirable


  • Understanding of the clinical study and drug development process
  • Knowledge of ICH/GCP Guidelines
  • Knowledge of SAE reporting requirements
  • Relevant industry or health care experience
  • Demonstrates ability and willingness to work cross-functionally, on global level
  • Ability to concisely summarize large amounts of complex information
  • Programming experience in data analysis and/or data mining set-up (e.g. Python, R, SAS)
  • Experience using data review tools such as JReview, JMP Clinical, or Spotfire
  • Statistic knowledge

Key Skills

Ranked by relevance

c ai ha data analysis ui excel esp lan data mining outlook python gcp sas cis aci nat
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Country Guide

Poland

Fast-growing Central European IT hub

Posted
Nov 26, 2024
Type
Full-time
Level
Entry
Location
Warsaw
Company
AstraZeneca

Industries

Pharmaceutical Manufacturing

Categories

Research Analyst Information Technology

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