PRAHS

  • Clinical System Designer II (Deerfield IL, Raleigh NC, or Blue Bell PA)

    Job Locations - | US-IL-Chicago | US-NC-Raleigh | US-PA-Blue Bell
    Posted Date 2 days ago(2 days ago)
    ID
    2018-48256
  • Overview

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    Who are we?

    We Are PRA.

    We are 15,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most

     

    Who are you?

    You are a RAVE experienced/certified Clinical Systems Designer, who uses technical, industrial, and interpersonal skills to create case report forms (CRFs) for trials.

    Responsibilities

    What will you be doing?

    Uses technical, industrial, and interpersonal skills to create case report forms (CRFs) for trials.

    • Designs electronic case report forms (CRFs) by utilizing experience of electronic data capture at clinical sites.
    • Creates and supports the delivery of the full clinical data management system.
    • Participates in requirements-gathering sessions with biostatisticians, data management, and study teams.
    • Keeps up with trends in electronic data capture software to maximize productivity.
    • Creates case report forms (CRFs) and data-entry screens for paper-based data collection trials
    • Acts as the primary point of contact during study build for design related questions by the project team.
    • Consolidates the high-level system requirements for the trial by creating the draft Clinical System Design Guide (CSDG) and independently
    • Functions as Lead Designer with responsibility for creating the CRFs, data-entry screens, dynamic and edit check plans and critical variable lists copying and modifying CRFs from standard libraries and other studies as appropriate and ensure compliancy of use of standards is met.
    • Creates and maintains standard libraries for use in designing, developing, and testing all system components for a trial.
    • Provides support and review for the re-use of library items
    • With assistance assembles edit programs from the appropriate library and modify the library edit programs to meet trial-specific requirements.
    •  Reviews, where appropriate, test plans created by the clinical system tester

    • Creates custom reports and standard objects as requested
    • Performs peer review of CRFs, dynamic check plans, and other clinical system development documents, as assigned, and captures all comments from the study team and client.
    • Assists, under instruction in the development of materials for the bid defense process and client demonstrations.
    • Helps prepare materials and participate in industry meetings as a representative of PRA.
    • Acts as a Subject Matter Expert (SME) within a chosen field of CSD. Assists, under instruction of the development and implementation of improvements to CSD systems and processes within the SME role.  
    • Organizes, creates, and oversees the administration of training and mentoring for junior levels.
    • May, supervise up to three individuals with assistance from functional management and acts in place of the functional manager during an absence. 
    • Obtains required approvals for the release of system components to the live/production environment.

     

     

    Qualifications

    What do you need to have?

    • Bachelor’s degree in a technological or clinical field required.
    • Minimum of 5 years of clinical design experience required.
    • Must be RAVE trained/experienced. RAVE certification strongly preferred. Experience with RAVE migrations (documentation and post-migration steps) desired.
    • Experience with integrations with IXRS preferred.
    • Prior CRO experience required.
    • Must have prior experience building from the protocol. Must be able to read and understand protocol, and develop new CRFs with minimal support.
    • Must be comfortable interfacing directly with clients and internal cross-functional teams (Lead Data Managers, Developers). 

    To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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