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Trial Data Manager

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Trial Data Manager

Pharmaceuticals

Remote

Description

 

Trial Data Manager

We are looking for a Trial data Manager to be part of this global team with the focus is more on specification than the actual build phase working on a number of Clinical trials across multiple therapeutic areas.

Role

 

  • Implementation, monitoring and supervision of data management activities within assigned clinical trials
  • Design, create, validate, review, approve and maintain data management tool specifications, including but not limited to: eCRFs and their set-up in EDC system, Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans (DRPs) and Data Management Plans (DMPs).
  • Provision of adequate sponsor oversight of data management CROs or external data providers
  • Filing and archiving of trial documentation
  • Creation and execution of data quality checks throughout study conduct

Experience

 

  • At least 6-10 years’ experience within Clinical Data Management either within a Pharma or CRO environment with a proven track record of quality
  • Knowledge in and experience with the use of Data Collection Tools (EDC systems), Data Review Tools, and/or Data Standardization methods and requirements is a plus
  • Understanding of dependencies among interfaces
  • Experience in working in/with agile teams and/or as a product owner is a plus
  • Ability to independent decision making and problem solving
  • Excellent communication and fluency in English in speaking and writing
  • Understanding of CDISC standards (CDASH, SDTM, etc.…) and SAS is a plus but essential
 

This is a long-term engagement working remotely in either the UK/Ireland  or Europe.  If based in the UK this will be outside of IR35.

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Job Details

  • Job Type:

    Contract
  • Rate:

    Negotiable
  • Job published:

    about 2 months ago
  • Reference:

    BBBH8699