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2017-43269

2017-43269

Title 
Data Manager Technical Expert
Job Locations 
-
United Kingdom-Livingston, Scotland
Posted Date 
10/4/2017

More information about this job

Overview

As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and / or international regulatory approval of 45+ such drugs.  At PRA Health Sciences, providing innovative solutions for our clients is what we do.  From full service clinical development to the pioneering Embedded Solutions model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.

 

At PRA, borders do not create boundaries.  PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals.  Our growing workforce is comprised of over 15,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.

Responsibilities

PRA is pleased to announce we are hiring experienced Clinical Programming Data Acquisition Expert to join our Strategic Solutions division. This position acts as a deployment expert in the technical aspects of data management to ensure latest standards are being utilized, current technologies are deployed and system integrations are optimized.  At the trial level, this position will drive use of standards for CRF builds and ensure best practices are used for edit checks, reports, and integrations.  Additionally, this position will determine, in conjunction with the team, the data models required (SDTM, non-SDTM), will review data models for compliance with standards and will assist with the creation of new CRF, edit check, mapping and submission standards if needed

 

This is an excellent opportunity for career development, be dedicated with a top pharmaceutical client and work as part of a dedicated team of Lead Data Managers & technical experts at our growing Livingston office.

 

Duties will be:

  • Primarily accountable for providing expertise in technical data management activities, including:
    • CRF technical development
    • Data model specifications and mapping (SDTM)
    • Data stream integrations
    • Programs, Reports and Visualisations for data review
    • electronic CRF (eCRF) submission packages
  • Partnering Lead Data Managers and Standards Experts
    • Evaluate and propose optimal technical solutions to meet protocol requirements
    • Determine implementation plans
    • Provide hands-on programming as appropriate
  • Tracking milestones and tasks for assigned projects
  • Ensuring timely completion of all project status reporting
  • Interfacing with team members across all departments as needed
  • Ensuring project deliverables are achieved in terms of timelines and quality
  • Setting timelines for CRO/study team

Qualifications

In order to be considered for the role at PRA, you will ideally have an undergraduate Life Science degree with demonstrable industry experience within Clinical Data Management, Clinical Programming and or Database Design.

 

Other skills required are:

  • Excellent written and oral communication skills.
  • Read, write and speak English
  • Medidata Rave EDC experience in: design, set-up and use from a programming or design perspective.
  • Working knowledge of Clinical Data Tools such as: LSAF, Pinnacle 21 and CDISC Standards (SDTM), CDASH and define.xml.
  • Experience within Data Management programming such as: Database programming, Edit check programming and listing programming
  • Experience of working with vendor data and creating Data Transfer Agreements
  • Experience of working with or programming of visualization tools such as Spotfire.
  • SAS programming experience

Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment.  As we continue to expand, there will be career opportunities on a truly global scale.

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