ERT Solutions Design Analyst (Requirements Engineer) in Boston, Massachusetts
Are you ready to make a real difference? ERT has a temp-to-hire Solutions Design Analyst opportunity! In this role, you will 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.
Ask your recruiter for more information about how ERT's temp-to-hire process works!
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.
As a Solutions Design Analyst, your essential work will include
Coordinating the overall Solutions Design Process for our clients (Trial Sponsors)
Gathering sponsor requirements and suggesting ERT's best design components to support those requirements
Creating and maintaining specs for study-specific implementations
Ensuring consistency between trial data capture, data delivery and database structures to meet client requirements
Managing the Design Process including communication of design requirements internally and externally with the Customer. This includes participation in internal and external design milestone meetings
Collaborating with internal teams such as Project Management (to establish and refine scope definitions), Clinical Systems Translation & Licensing (CSTL) (on proper trial questionnaires) and Data Management to ensure the right data is collected to satisfy the sponsor's study needs
Collaborating with other departments for testing requirements; to support related study issues, and to assist with project scoping and/or change control processes
Supporting Product Development, Process Development and Study tracking efforts
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.
This is a big job - we need highly skilled folks on the team!
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 equivalent
Ability to understand and interpret clinical trial documentation such as protocols, questionnaires and other data collection instruments, and clinical data models
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 attention to detail
Excellent presentation, communication (written and oral) and negotiation skills
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.
External Company Name: eResearch Technology
External Company URL: www.ert.com
Street: 500 Rutherford Ave