Solutions Design Analyst (Requirements Engineer)


  • Company:
    ERT
  • Location:
  • Salary:
    negotiable / Month
  • Job type:
    Full-Time
  • Posted:
    2 weeks ago
  • Category:
    Engineering

ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so we 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. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more than 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. Are you ready to join us as a Solutions Design Analyst and help us design the blueprint for Clinical Trial Software? Take responsibility for delivering the highest quality eCOA solutions design consultation to our pharmaceutical/biotechnology industry clients.  You will be aligned with one or more project teams as well as interface with clients and ERT solutions delivery leadership to ensure that clinical protocols are mapped to software solutions efficiently, accurately, and within project scope.  Essential Duties and Responsibilities: Solutions DesignCoordinate the overall Solutions Design Process ensuring that clinical protocols are appropriately mapped to software solutions efficiently, accurately and within project scopeDevelop and communicate design best practices for specific therapeutic areasGather and document sponsor requirements and specify design components to support those requirementsCreate and maintain specifications for study-specific implementations of ERT products and services using a Documentation Management SystemEnsure consistency between trial data capture, data delivery and database structures to meet client requirementsResponsible 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 meetingsCollaborate 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 studyCollaborate with Clinical Systems Translation & Licensing (CSTL) to confirm correct versions of copyrighted questionnaires are implementedTrack Design related milestones and timelinesSupport Solutions Validation/Quality Control testing by addressing any defects associated with the design in a timely mannerCollaborate with other departments to investigate study issues found beyond the start-up phase of the studyCollaborates 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 solutionAssist in project scoping and change control processes, including revision management Product DevelopmentProvide feedback to Product Development group on new product functionality Process DevelopmentProvide input to interdepartmental process improvement initiatives AdministrationTrack time for billable study related and non billable tasks in a timely mannerTrack SDA milestone start and completion dates using the ERT project scheduling toolComplete activities in the Training Management System in a timely manner Other Duties and Responsibilities: Perform other duties as directed by Solutions Design ManagementThe 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.  Qualitifications and Skills Needed:BS, BA or equivalent ( Degree in science/healthcare-related field a plus)Minimum of 3 years of experience in the execution of clinical trials or equivalentAbility to understand and interpret clinical trial documentation such as protocols, questionnaires and other data collection instruments, and clinical data modelsDemonstrated experience in interpretation of client requirements to prepare and document design specificationsProven experience in client relations and interactions with clients at all levelsFamiliarity with FDA regulatory processes, clinical research processesSelf -directed – comfortable working in a fast-paced environmentAbility to manage multiple project tasks and deliverablesProven problem-solving skills and attention to detailExcellent presentation, communication (written and oral) and negotiation skillsAbility 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.