• Clinical System Designer/Clinical System Developer - Boston

    Job Locations (All) | US-MA-Boston
    Posted Date 1 month ago(1/18/2019 10:07 AM)
  • Overview

    Do you want to watch clinical development change, or do you want to be the one to shape it?


    Because we’re hoping you’re here for the latter.


    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 are getting live saving drugs into the hands those who need them most.


    Who are you?

    You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Clinical System Designer/Clinical System Developer, you want to change the future.  You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. 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.




    What will you be doing?


    As a Clinical System Designer/Clinical System Developer you will be 


    • 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 (CFRs) and data-entry screens for paper-based data collection trials.


    • Acts as the primary point of contact for questions by the project team.


    • Consolidates the high-level system requirements for the trial by creating the draft clinical system design guide (CSDG) and ensuring its review by all appropriate reviewers.
    • 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 essential  support and review for the re-use of library items.
    • Assembles edit programs from the appropriate library and modify the library edit programs/listings 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, ensures CDC review of EC plan and maintains all comments from the
      study team and client.
    • Provides suggestions and helps develop materials for the bid defense process and client demonstrations.
    • Prepares materials and participates in industry meetings as a representative of PRA.
    • Leads a team of subject matter experts and supervises individuals with assistance from functional management. Leads the development and
      implementation of improvements to CSD systems and processes within the SME role. Where required actively participate in external professional activities and organizations to
      support the SME role.
    • Organizes, creates, and oversees the administration of training and mentoring for junior levels.
    • May supervise up to five 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.


    What do you need to have?


    Education: Bachelor’s degree in a technological or clinical field


    Skills: 8 years of clinical design experience

    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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