Senior Clinical DB Designer

IQVIA LLC; Bengaluru; On-site; INR 1,800,000 - 2,700,000; Full time

Job summary

IQVIA LLC is seeking a Senior Technical Designer to lead study build and design activities, including editing specifications, configuring systems, and aligning with SDTM/CDASH standards. You will coordinate with DTL, programmers, validation, vendors, statisticians, and client representatives to ensure timely, accurate deliverables.

The role also covers responsibility for study design from a project-financial perspective within the programming shared services, plus driving process improvements

Qualifications

• 7+ years of core Technical designer experience.
• Bachelor’s degree in Science/Computer Science/Information Technology or Bachelor in Technology.
• Experience with defining study design components and EDC/CDMS tools.

Responsibilities

• Interprets the study protocol.
• Design and update the eCRF using third party or in house CDMS tools in alignment with 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; may lead Online Screen Review Meeting.
• Facilitate the internal Edit Specification Review Meeting and lead 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.
• Communicate any project risks to the Data Team Lead, including potential timeline misses.
• Escalate potential quality issues.
• Ensure completion of all project-specific training and adherence to SOPs.
• Review build timelines and provide input; review QIP for own projects and identify out of scope activities.

Skills

Technical designer experience

Bachelor's degree in Science/CS/IT orB

Education

Bachelor's Degree in Science/CS/IT or Bachelor in Technology

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. 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.