Analyst, Clinical Trial Safety

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Job Description:

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.

Typical Accountabilities:

• Supporting Senior Analyst and Associate Director, Analyst in their activities

• Data Review tool set-up, maintenance and close-out of studyaccording to agreedBest Practice procedures– to allow for handling of safety data and review formedical completenessandmedical accuracy

• Generation of high quality reportsthat are aligned forTRISARC membersand theGlobal Therapeutic Areas

• Work with data outputs(i.e., generate reports, macros/scripts) from multiple sources such as theclinical database,external labs,ECG providers, and othersafety vendorsas appropriate

• Generate summary reports

• Analyze and visualize clinical datafrom different sources including but not limited toeCRF,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 workincluding training activities, continuous improvement, and development of procedures as needed

• Perform quality check of documentsandfile 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/participatein different type of meetings

Education, Qualifications, Skills and Experience:

Essential:

• 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

Desired:

• 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

Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

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