Senior Clinical DB Designer

IQVIA Argentina; Hyderabad; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

IQVIA Hyderabad is seeking an experienced Technical Designer to lead study build and design, edit specifications, and configure InForm/CDMS components in alignment with SDTM and CDASH standards.

This role collaborates with DTL, programmers, validation teams, vendors, statisticians, and client representatives to ensure timely study delivery and accurate project financials from the programming shared services perspective.

Qualifications

• Bachelor's Degree in Science/Computer Science/Information Technology or Bachelor in Technology required.
• 7+ years of relevant core Technical designer experience.

Responsibilities

• Interprets the study protocol.
• Design and update the eCRF using CDMS tools aligned with SDTM/CDASH.
• Create and update Edit Specification Document.
• Generate specifications for EDC build components (Rights and Roles, System Settings and Home Page).
• Complete the Study Authorization Form and Trial Capacity Request Form (InForm).
• Attend design review meetings and present comments; may lead Online Screen Review Meeting.
• Facilitate internal Edit Specification Review Meeting and lead discussions on the document.
• Design the database to collect LLRR data within InForm database with proper access rights.
• Communicate project risks to the Data Team Lead and escalate quality issues.
• Ensure completion of project-specific training and adherence to SOPs.
• Review build timelines and provide input; review QIP for own projects.
• Manage multiple study design projects across platforms.
• Identify areas for process improvements and contribute to continuous improvement.

Skills

Study design

Cross-functional collaboration

Project coordination

Education

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

Tools

CDMS tools

SDTM/CDASH standards

Job description

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 Req
• 7+ years of relevant core Technical designer experience

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 committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.