Senior Technical Study Designer (Home-based)

IQVIA LLC; Columbus (OH); Remote; USD 82,000 - 138,000; Full time

Job summary

An innovative firm is seeking a Senior Technical Study Designer to lead the design and build of clinical study components. This role offers a unique opportunity to collaborate with diverse stakeholders and manage multiple projects, ensuring adherence to industry standards. You will be responsible for creating and updating essential documentation while identifying areas for process improvements. Join a forward-thinking company committed to enhancing patient outcomes through innovative medical solutions. If you have a passion for technology and a desire to make an impact, this position is for you.

Qualifications

• 2-4 years of relevant core Technical designer experience.
• Bachelor's Degree in Science/Computer Science/Information Technology.

Responsibilities

• Responsible for study build & design, edit specifications, and system configurations.
• Collaborate with stakeholders and manage project financials.

Skills

Technical Design

eCRF Design

Database Design

Project Management

Process Improvement

Education

Bachelor's Degree in Science/Computer Science/Information Technology

Tools

CDMS Tools

InForm

Job description

Senior Technical Study Designer (Home-based) page is loaded

Senior Technical Study Designer (Home-based)

Apply locations Columbus, Ohio, United States of America time type Full time posted on Posted Yesterday job requisition id R1480699

Job Overview

Responsible for study build & design, edit specifications, system configurations and is accountable for associated study design components. This role will collaborate with various stakeholders- DTL, Programmer, Validation Team, vendors, statisticians, and client representatives. In addition to project deliveries, the role also would be responsible for the project financials from programming shared services perspective.

Essential Functions

• Interprets the study protocol.

• Design and update the eCRF using third party or in house CDMS tools in alignment with industry standards like SDTM, CDASH as applicable.

• Create and update Edit Specification Document.

• Generate specifications for EDC build components (e.g., Rights and Roles, System Settings and Home Page)

• Complete the Study Authorization Form and Trial Capacity Request Form (InForm)

• Attend the Pre-Design Meeting, Online Screen Review Meeting, Unblinded Data review meeting. Attend and present comments at the Internal Design Review Meeting. May lead Online Screen Review Meeting.

• Facilitate the internal Edit Specification Review Meeting and leads the discussions regarding the Edit Specification Document.

• Design the database to collect LLRR data within the InForm database and ensure Rights and Roles document has appropriate access for Entry and Updates.

• Communicate any project risks to the Data Team Lead, including the potential for missing a timeline in the Data Management Project Plan.

• Escalate potential quality issues.

• Ensure the completion and documentation of all project-specific training, as well as staying current with required Standard Operating Procedures.

• Reviews build timelines and provide input as applicable.

• Reviews QIP for own projects, identify out of scope activities if any and inform relevant parties.

• Responsible for multiple study design projects at the same time.

• Might be working on projects across multiple platforms.

• Identify areas for process improvements on an ongoing basis. Actively take part and contribute towards process improvement initiatives as assigned besides providing suggestions for continuous improvement of processes.

• All responsibilities are essential job functions unless noted as nonessential (N).

Qualifications

• Bachelor's Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology

• 2-4 years of relevant core Technical designer experience and total exp being 7+ yrs. Req

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

The potential base pay range for this role, when annualized, is $82,300.00 - $137,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

About Us

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.