PRAHS

  • IxRS Specialist

    Job Locations (All) | US-NJ
    Posted Date 2 weeks ago(1/7/2019 8:33 PM)
    ID
    2018-49524
  • Overview

    Responsible for providing end-to-end IVRS support to clinical project teams including but not limited to gathering study specific IVRS user requirements, creating and enforcing IVRS standards, managing vendor performance, monitoring system change requests, and supporting training & education for stakeholders.

    Responsibilities

    • Execute IVRS development process from kickoff to system go live, ongoing system change control, and system closeout.
    • Work with the internal stakeholders and IVR vendors to develop study specific IVR requirements, creates and enforces the use of IVRS standards. Responsibilities may include collaboration with vendors and internal stakeholders to define requirements and develop implementation plans. Ensures adherence to IVRS standards, reviews study team business case proposals, and provides final go / no-go decision regarding requests to utilize custom functionality.
    • Manage vendor performance and relationship(s) at the study level. Responsibilities may include performing root cause analysis and identifying corrective/preventative actions, and serving as a point of escalation for vendor issues.
    • Ensure vendor system development processes align with Sponsor Quality and System Life Cycle expectations.
    • Monitor system change requests. Ensure adherence to IVRS standards, works with the clinical project team to identify system changes and ensure completion of the changes through its life-cycle. Monitors and analyzes system change requests, and identifies corrective actions for utilization of standards.
    • May provide support in the following areas:
      • data transfer issue resolution between IVRS vendors and shipping depots in support of shipping processes, DOF/ERP specifications, and issue resolution.
      • lock & transfer of allocation schedules to IVRS vendors, the requirement document approval process, or the provision of site & Sponsor user information to IVRS vendors.
      • development / maintenance of relevant documentation, including applicable SOPs, job aids, and guidance documents.
      • process improvement activities.
      • training and education for stakeholders including develop, or assist in development of, reference and/or training material; may provide cross-functional internal and external communication as needed.

    Qualifications

    Education and Work Experience:

    • 2-4 years of experience in clinical supplies, clinical research, or database design & development
    • B.A./B.S. in biology, life sciences, computer science, or related field
    • 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.

    Knowledge, Skills, and Abilities:

    • Demonstrated knowledge of IVRS development processes.
    • High level understanding of clinical supply chain within the pharmaceutical industry.
    • Knowledge of databases, structure, & corresponding tools used to manage, extract, & report data.
    • Working knowledge of clinical development and statistical concepts.
    • Effective written and verbal communication skills.
    • Ability to organize and manage multiple tasks at one time and meet deadlines in a complex environment working both internal to Sponsor and external to Sponsor.
    • Average proficiency with Microsoft applications (Word, Excel, PowerPoint, Project).
    • Working knowledge of regulatory requirements (e.g., GMP), quality procedures and SOP execution.





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



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

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