ERT

  • Solutions Design Analyst, Imaging

    Job Location US-OH-Cleveland
    Shift
    Full-time/Regular
    Type
    Regular Full-Time
  • Overview

    The Solutions Design Analyst, Imaging is responsible for delivering the highest quality Imaging solutions design consultation to our pharmaceutical/biotechnology industry clients. The Solutions Design Analyst will be aligned with one or more project teams, as well as interface with clients and ERT solutions delivery leadership. The Solutions Design Analyst will ensure that clinical protocols are mapped to software solutions efficiently, accurately, and within project scope.

     

    ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that our customers can move ahead with confidence. With more than 45 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so it can adapt without compromising standards.

    Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement, and measure the efficacy of new clinical treatments while ensuring patient safety. Over the past four years, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, Biotechs, and CROs have relied on ERT solutions in 9,500+ studies spanning three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly – and with confidence. For more information, go to ert.com or follow us on LinkedInTwitter, and Facebook.

    Responsibilities

    ESSENTIAL DUTIES AND RESPONSIBILITIES:

     

    1. Solutions Design
            • Coordinate the overall Solutions Design Process ensuring that clinical protocols are appropriately mapped to software solutions efficiently, accurately, and within project scope.
            • Develop and communicate design best practices for specific therapeutic areas.
            • Gather and document sponsor requirements and specify design components to support those requirements.
            • Create and maintain specifications for study-specific implementations of ERT products and services using a Documentation Management System.
            • Ensure consistency between trial data capture, data delivery, and database structures to meet client requirements.
            • Responsible for the overall management of the Design Process including communication of design requirements internally and externally with the Customer.  This includes participation in internal and external design milestone meetings.
            • Collaborate with Project Management to establish and refine scope definition for the project, as well as provide work effort/duration/risk assessment estimates pertaining to Design related items through the life cycle of the study.
            • Coordinate the handoff of a finished software product to the Project Manager and provide training on the solution created.
            • Track Design related milestones and timelines.
            • Support Solutions Validation/Quality Control testing by addressing any defects associated with the design in a timely manner.
            • Collaborate with other departments to investigate study issues found beyond the start-up phase of the study.
            • Collaborate with DM to ensure that the software solution captures the necessary data points for data extraction and that the Data Management Plan supports the software solution.
            • Assist in project scoping and change control processes including revision management.
    1. Product Development
      • Provide feedback to Product Development group on new product functionality.
    2. Process Development
      • Provide input to interdepartmental process improvement initiatives.
    3. Administration
      • Track time for billable study related and non-billable tasks in a timely manner.
      • Track SDA milestone start and completion dates using the project scheduling tool (if applicable).
      • Complete activities in the Training Management System in a timely manner.

     

    OTHER DUTIES AND RESPONSIBILITIES:

     

    1. Perform other duties as directed by Solutions Design Management.

     

    The duties and responsibilities listed in this job description represent the major responsibilities of the position.  Other duties and responsibilities may be assigned, as required. ERT reserves the right to amend or change this job description to meet the needs of ERT.  This job description and any attachments do not constitute or represent a contract.

    Qualifications

    QUALIFICATIONS AND SKILLS NEEDED:

     

    Education:

    • BS, BA or equivalent (Degree in IT or science/healthcare-related field a plus)

     

    Experience:

    • Minimum of 2-3+ years of experience writing technical software requirements or equivalent
    • Minimum of 2-3+ years of experience in the execution of clinical trials or equivalent strongly preferred
    • Demonstrated ability to understand and interpret medical terminology and clinical trial documentation such as protocols, acquisition guidelines, and product user manuals
    • Demonstrated experience in interpretation of client requirements to prepare and document design specifications
    • Proven experience in client relations and interactions with clients at all levels
    • Familiarity with FDA regulatory processes, clinical research processes
    • Self-directed; comfortable working in a fast-paced environment
    • Ability to manage multiple project tasks and deliverables
    • Proven problem-solving skills and high attention to detail
    • Excellent presentation, communication (written and oral), and negotiation skills
    • Ability to travel up to 25%

     

    The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications.

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