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Clinical Trial Safety Analyst (TRISARC)

Location Warsaw, Mazovia, Poland Job ID R-110860 Date posted 11/06/2021

Development Operations within Biopharmaceutical R&D is accountable for the delivery of clinical studies.

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 Clinical Trial Safety Analyst (CTSA)in Trial Safety Review Centre (TRISARC) is responsible for tools set-up, scripting, and data analysistasks for the Trial Safety Review Center. The CTSA works closely with the Trial Safety Review Center staff to ensure safety data deliverables are executed per pre-defined plans and up to quality and timelines. The CTSA is adept at utilizing the Center’s Data Review tools of choice and should possess programming experience.

TypicalAccountabilities:

  • Ensure the Data Review tool is fit for purpose through 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

  • Generate high quality Clinical/Safety Data Review reports that are aligned for TRISARC members and the Global Therapeutic Areas

  • Work with data outputs (i.e. generate reports,complex data) from multiple sources such as the clinical database, external labs, ECG providers, and other safety vendors as appropriate. 

  • 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)

  • Take on ad-hoc tasks as assigned by the TRISARC Leadership team members(e.g., capacity reports, business intelligence)

Education, Qualifications, Skills and Experience

Essential:

  • Universitydegreeinrelateddiscipline

  • Minimum one year of experience working on clinical studies in the Biotech/Pharma/CRO industry or equivalent

  • Provenorganizationalandanalyticalskills

  • Understanding of the clinical study and drug development process 

  • Knowledge of ICH/GCP Guidelines 

  • 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

  • Independently designing and planning own work

  • Managing change and uncertainty for self

  • Computer proficiency including Microsoft Outlook, Excel and Microsoft Power Platform

  • Excellent knowledge of spoken and written English

  • Strong attention-to-detail, analytical skills, and ability to concisely summarize large amounts of complex information

  • Exhibit of AZ Values andBehaviours

Desirable :

  • 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 prioritiesExperience using data review tools such asJReview, JMP Clinical, or Spotfire



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

50056723 D SCPT R&D BioPharmaceuticals

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.