Standards Developer I
AstraZenecaPoland - warsawUpdate time: July 21,2021
Job Description

Data Standards Support group is working on Data Collection and Cleaning Components which are necessary to electronic database preparation for capturing Clinical Trial data.

The Standards Developer I in Data Collection Standards team is primarily responsible for providing support to deliver lower complexity data management Clinical Data Standards (data collection and cleaning components) for assigned clinical projects. The core activity is focused on changes in the functioning of eCRF Specification, eCRF Instruction and Edit Check Specification, involving the adaptation of existing structures to the needs resulting from new and planned research across different Therapeutic Area. Liaises with variety of departments on a local level to ensures delivery of data collection components.  May work under direction of a Senior or Principal Standards Developer.

Typical accountabilities:

  • Under supervision, develops and maintains lower complexity data collection and cleaning components
  • Monitors, develops, and updates requests within defined system
  • Leads quality of own deliverables and completeness of applicable quality and process documentation
  • Collaborates with other Standards Developers
  • Seeks to acquire knowledge of data management standards development processes
  • Takes steps to understand the roles and skills of others in clinical data standards
  • Takes steps to understand the roles and skills of other functions in drug development
     

Education, Qualifications, Skills and Experience

  • BSc in Information Sciences, Mathematical, Statistical, Computer Science or Life Science or equivalent experience.
  • Knowledge of MS Excel, deep attention to the details, analytical thinking, strong oral and written communication skills and a systematic approach to work is required.
  • Must have the ability to work as part of a team, as well as to work independently, with minimal supervision. For new activity members full training will be provided.
  • Additional benefit would be knowledge of the existence of industry standards (eg, CDASH, SDTM, ADaM).
  •  Experience with clinical data standards (eg, in Data Management, Programming, Statistics).
  • Ability to understand and adhere to business processes, understanding of programming languages (eg, SAS, R, Java, Groovy, Spotfire, C/C++, VBA/VBS, .NET, Python, Pearl)

Date Posted

20-lip-2021

Closing Date

12-sie-2021

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 authorization and employment eligibility verification requirements.

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