Job Description:

Solutions Design Analyst (Requirements Engineer)

Job Location

US-MA-Medford | US-MA-Medford

Overview

Are you ready to make a real difference? ERT has a 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 align with our project teams and interface with clients and ERT solutions delivery leadership to 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 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.

Responsibilities

As a Solutions Design Analyst, your essential work will include

Coordinating the overall Solutions Design Process for our clients (Trial Sponsors)
1. Gathering sponsor requirements and suggesting ERT's best design components to support those requirements


2. Creating and maintaining specs for study-specific implementations


3. Ensuring consistency between trial data capture, data delivery and database structures to meet client requirements


4. 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


5. 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


6. Collaborating with other departments for testing requirements; to support related study issues, and to assist with project scoping and/or change control processes


7. 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.

Qualifications

This is a big job - we need highly skilled folks on the team!

What we seek:

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


2. Minimum of 3 years of experience in the execution of clinical trials or equivalent


3. Ability to understand and interpret clinical trial documentation such as protocols, questionnaires and other data collection instruments, and clinical data models


4. Demonstrated experience in interpretation of client requirements to prepare and document design specifications


5. Proven experience in client relations and interactions with clients at all levels


6. Familiarity with FDA regulatory processes, clinical research processes


7. Self -directed - comfortable working in a fast-paced environment


8. Ability to manage multiple project tasks and deliverables


9. Proven problem-solving skills and attention to detail


10. Excellent presentation, communication (written and oral) and negotiation skills


11. Ability to travel up to 25%

What we offer:

• Competitive Salary plus Annual bonus target


• Excellent On-Boarding plan


• Global Exchange Program


• Exceptional Tuition Reimbursement scheme


• Comprehensive Benefits Package, including a generous paid time off program

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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