Analyst, Clinical Trial Safety

Durham, NC

Full-time

Hybrid

Entry Level

AstraZeneca is a global biopharmaceutical company dedicated to sustainability and innovation. The Analyst, Clinical Trial Safety will support the review of clinical trial safety data, ensuring completeness and accuracy while collaborating with various teams to produce high-quality reports and maintain data tools.

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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
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) contain up-to-date information, documents, files; coordinate updates, if needed
Support preparation/participate in different type of meetings

Qualification

Required

Bachelor degree in related discipline
1+ years of analytical experience
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
Excellent knowledge of spoken and written English
Exhibit of AZ Values and Behaviours

Preferred

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

Benefit

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

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