ERT

Solutions Design Associate

US-MA-Boston
Shift
Full-time/Regular
Type
Regular Full-Time

Overview

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.

 

Join us in our Boston office as a Solutions Design Associate!  In this role, you will be responsible for assisting study design analysts in everyday tasks related to ePRO and eCOA study delivery.  Generally speaking, you can expect to be aligned with one or more project teams as well as to interface with other ERT internal functions.

Responsibilities

Essential Duties and Responsibilities: 

  1. Study Design 
    • Coordinate the overall Solutions Design Process (with overview) ensuring that clinical protocols are appropriately mapped to software solutions efficiently, accurately and within project scope
    • Create and maintain specifications for study-specific implementations of ERT products and services in a Documentation Management System
    • Collaborate with Clinical Systems Translation & Licensing (CSTL) to confirm correct copyright versions for questionnaires are implemented
    • Track Design related milestones and timelines.
    • Coordinates with Quality Control and Software Development teams to ensure accurate understanding, implementation and testing of the requirements documented in the functional specifications.
    • Responsible for fixing any defects associated with design aspects in a timely manner.
    • Collaborate with other departments to investigate study issues found beyond the start-up phase of the study.
  1. Product Development
    • Provide feedback to Product Development group on new product functionality
  1. Administration
    • Track time for billable study related and nonbillable tasks
    • Perform other duties as directed by Solutions Design Management

Other Duties and Responsibilities (to be performed as needed)

    • Other study-design related duties and projects as assigned.

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

  1. BS, BA or equivalent; Masters Degree in science/healthcare-related field a plus
  2. Prior experience working within a clinical setting and/or with exposure to data management systems very helpful
  3. Ability to understand and interpret clinical trial documentation such as protocols, questionnaires and other data collection instruments, and clinical data models
  4. Ability to acquire and apply understanding of clinical trial data management and database structure and design
  5. Familiarity with FDA regulatory processes
  6. Self directed - comfortable working in a fast-paced environment
  7. Ability to manage multiple project tasks and deliverables
  8. Proven problem-solving skills and attention to detail
  9. Excellent presentation, communication (written and oral) and negotiation skills
  10. Ability to travel up to 25%

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. 

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