Senior Technical Study Designer (Home-based)

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

Job summary

An established industry player is seeking a detail-oriented Study Designer to lead study build and design efforts. This role involves collaborating with various stakeholders, managing project financials, and ensuring compliance with industry standards. The ideal candidate will have a strong technical background and the ability to handle multiple projects simultaneously. If you are passionate about clinical research and eager to contribute to innovative solutions in healthcare, this opportunity is perfect for you.

Qualifications

• 7+ years of total experience with 2-4 years in core technical design.
• Strong understanding of industry standards like SDTM and CDASH.

Responsibilities

• Responsible for study build, design, and editing specifications.
• Manage multiple study design projects and facilitate internal meetings.

Skills

Study Design

eCRF Design

Data Management

Project Management

Technical Design

Stakeholder Communication

Education

Bachelor's Degree in Science

Bachelor's Degree in Computer Science

Bachelor's Degree in Information Technology

Tools

InForm

CDMS Tools

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 the 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 meetings such as Pre-Design, Online Screen Review, Unblinded Data review, and Internal Design Review; may lead some meetings.
7. Facilitate internal Edit Specification Review Meetings and lead discussions on the document.
8. Design the database to collect LLRR data within InForm and ensure appropriate access rights.
9. Communicate project risks to the Data Team Lead, including potential timeline issues.
10. Escalate quality issues as needed.
11. Complete and document all project-specific training; stay current with SOPs.
12. Review build timelines and provide input.
13. Review QIP for projects, identify out-of-scope activities, and inform relevant parties.
14. Manage multiple study design projects simultaneously.
15. Work across multiple platforms if required.
16. Identify and contribute to process improvements and ongoing initiatives.

Qualifications

• Bachelor's Degree in Science, Computer Science, Information Technology, or related fields.
• 2-4 years of core technical design experience; total experience of 7+ years preferred.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence. Learn more at https://jobs.iqvia.com.

IQVIA is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected status. More info at https://jobs.iqvia.com/eoe.

The potential base pay range is $82,300 - $137,100 annually, with actual offers based on qualifications, location, and other factors. Additional incentives and benefits may apply.