Covance

  • IRT Speciailist

    Job Location(s) US-NC-Research Triangle Park | US-PA-King of Prussia | US-PA-Philadelphia | US-NJ-Princeton | US-TX-Austin | US-IL-Chicago | CA-ON-Toronto | CA-ON-Mississuaga | US-MO-Kansas City
    Job Number
    2018-26091
    Job Category
    Clinical Data Management
    Position Type
    Full-Time
  • Job Overview

    IRT Specialist

    permanent, salaried

    Remote from anywhere in the U.S. or Canada.

     

    Responsibilities

    • Responsible for IRT system initial implementation, maintenance, and closure.
    • Ensure comprehensive understanding of requirements and design to provide quality deliverables.
    • Organizes kick-off meeting and team meetings.
    • Coordinates review and sign-off of requirements and release documents.
    • Directs teams during development and testing for initial implementation and updates.
    • Manages UAT planning and creates UAT documentation – UAT Test Plan, test scripts, and defect tracker.
    • Coordinates documentation and closure of issues.
    • Manages post-production change controls.
    • Facilitates database lock activities with study team, vendor, and other stakeholders. Coordinates decommissioning and archiving.
    • Advise the team and stakeholders, informing on the processes that will be completed to enable system implementation and updates.

    Experience Required

    • Minimum 3-5+ years of experience in clinical systems such as CTMS, ePRO, IXRS, EDC or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
    • Strong oral and written communication skills. Experienced project leader and presenter.
    • Able to work both independently and collaboratively across multiple functional areas.
    • Proficiency in converting complex technical and business requirements into clear test plan and test cases.
    • Understanding of Drug Development and Clinical Trial Processes
    • Understanding of Data Management Processes
    • In-depth knowledge of Good Clinical Practices
    • Understanding of Clinical Research System Development Lifecycle
    • Must have sound problem resolution, judgement and decision-making skills.
    • Ability to prioritize tasks effectively and manage multiple projects simultaneously.

     

    Education/Qualifications

    • Degree in a mathematical, computing, life sciences, or related discipline

    Experience

    • Minimum 3-5+ years of experience in clinical systems such as CTMS, ePRO, IXRS, EDC or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
    • Strong oral and written communication skills. Experienced project leader and presenter.
    • Able to work both independently and collaboratively across multiple functional areas.
    • Proficiency in converting complex technical and business requirements into clear test plan and test cases.
    • Understanding of Drug Development and Clinical Trial Processes
    • Understanding of Data Management Processes
    • In-depth knowledge of Good Clinical Practices
    • Understanding of Clinical Research System Development Lifecycle
    • Must have sound problem resolution, judgement and decision-making skills.
    • Ability to prioritize tasks effectively and manage multiple projects simultaneously.

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