PRAHS

  • eTMF Analyst (Blue Bell, PA or REMOTE)

    Job Locations (All) | US-PA-Blue Bell | US-Remote
    Posted Date 2 days ago(10/19/2018 6:13 PM)
    ID
    2018-47725
  • Overview

    Would you like to assist in the maintenance of Clinical Drug Studies for one of the largest pharmaceutical companies in the world?

     

    Who are we?

    We Are PRA.

     

    We are 14,000+ 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 are getting live saving drugs into the hands those who need them most.

     

    Who Are You?

    You are an experienced eTMF Analyst who is responsible for  tracking and maintening an electronic Trial Master File including in-house management of documentation generated by the clinical sites. You  handle regulatory documents and help to review Clinical Study Contracts and Budgets. You provide excellent support to not only your project teams but also to clients. You are excited and enthusiastic. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.

     

    Still here? Good. Because if this is you, we’d really like to meet you.

    Responsibilities

    Responsibilities include providing TMF support across functional areas, and management of electronic TMF records. Working with study teams and individual TMF owners to establish study-specific TMF structure and to ensure quality of TMF and TMF content, according to the established processes. Collaboration with user community to promote TMF quality to meet inspection readiness standards. Monitoring the quality, completeness, and overall inspection readiness rates of the TMFs for all functional areas managing TMF content.

    Qualifications

    REQUIRED EXPERIENCE:

    • 2+ years of related experience required
    • Prior experience using computerized information systems.
    • Read, write, and speak fluent English; fluent in host country language required 
    • Industry experience directly involved with the collection and creation of a variety of TMF content
    • Undergraduate degree or its international equivalent in clinical, science, or health related field from an accredited institution or a licensed healthcare professional


    PREFERRED EXPERIENCE:

    • Clinical trials support or pharmaceutical industry experience preferred.
    • Experience directly involved with the collection and creation of a variety of TMF content preferred
    • Knowledge of the complete clinical trial conduct process
    • Experience with PC-Windows, word processing, and electronic spreadsheets preferred.
    • Office based or clinical employment experience preferred.
    • Knowledge of ICH and local regulatory authority drug research and development regulations preferred.


    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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