Senior Technical Study Designer (Home-based)

IQVIA; Columbus (OH); On-site; USD 82,000 - 138,000; Full time

Job summary

An established industry player is seeking a Technical Designer to oversee study build and design processes. This role involves collaborating with various stakeholders to ensure the successful execution of study protocols and project financials. The ideal candidate will have a solid background in science or technology, with experience in designing eCRFs and managing multiple projects. Join a dynamic team committed to improving patient outcomes and population health globally, where your contributions will make a significant impact in the field of clinical research.

Qualifications

• 7+ years of experience in Technical Design with a focus on study build.
• Strong knowledge of industry standards like SDTM and CDASH.

Responsibilities

• Design and update eCRF using third-party or in-house CDMS tools.
• Manage multiple study design projects and communicate project risks.

Skills

Study Design

eCRF Design

Project Management

Stakeholder Collaboration

Process Improvement

Education

Bachelor's Degree in Science

Bachelor's Degree in Computer Science

Bachelor's Degree in Information Technology

Bachelor's Degree in Technology

Tools

CDMS Tools

InForm

Job description

Job Overview

Responsible for study build & design, editing specifications, system configurations, and accountable for associated study design components. Collaborates with stakeholders such as DTL, Programmers, Validation Team, vendors, statisticians, and client representatives. Also responsible for project financials from programming shared services perspective.

Essential Functions

1. Interpret the study protocol.
2. Design and update the eCRF using third-party or in-house CDMS tools, aligned with industry standards like SDTM and CDASH.
3. Create and update the Edit Specification Document.
4. Generate specifications for EDC build components (e.g., Rights and Roles, System Settings, Home Page).
5. Complete the Study Authorization Form and Trial Capacity Request Form (InForm).
6. Attend and potentially lead meetings such as Pre-Design, Online Screen Review, Unblinded Data review, and Internal Design Review.
7. Facilitate the internal Edit Specification Review Meeting and lead discussions on the document.
8. Design databases for LLRR data collection within InForm and ensure appropriate access rights.
9. Communicate project risks and escalate potential quality issues.
10. Ensure documentation of project-specific training and stay current with SOPs.
11. Review build timelines and QIP, identify out-of-scope activities.
12. Manage multiple study design projects simultaneously, possibly across multiple platforms.
13. Identify and contribute to process improvements and ongoing initiatives.

Qualifications

• Bachelor's Degree in Science, Computer Science, Information Technology, or Technology.
• 2-4 years of relevant core Technical Designer experience; total experience 7+ years.

IQVIA is committed to diversity and equal opportunity. Learn more at https://jobs.iqvia.com and https://jobs.iqvia.com/eoe.

Salary range: $82,300 - $137,100 annually, depending on qualifications and location. Additional incentives and benefits may apply.

Join us in our mission to improve patient outcomes and population health worldwide. Everyone at IQVIA contributes to this shared goal. Thank you for your interest in growing your career with us.