ERT Solutions Design Analyst, Imaging in St. Louis, Missouri
ERT - St Louis is searching for a Solutions Design Analyst, Imaging who will be responsible for delivering the highest quality Imaging software requirements and solutions design documents technical writing for our pharmaceutical/biotechnology industry clients. For each deployment, the Solutions Design Analyst will be aligned with a project team where they will analyze the provided scientific needs and develop specific written requirements that will be used to create a software solution for the client’s clinical protocol.
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 LinkedIn, Twitter, and Facebook.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsible for 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.
Ensure consistency between trial data capture, data delivery, and database structures to meet project/client requirements.
Responsible for the communication of design requirements including participation in design milestone meetings.
Collaborate with Project Management & Science teams 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.
Support Solutions Validation/Quality Control testing by addressing any defects associated with the design in a timely manner.
Collaborate with data management 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.
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 AND SKILLS NEEDED:
BS, BA or equivalent (Degree in IT or science/healthcare-related field a plus)
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.
External Company Name: eResearch Technology