Sr Clinical DB Designer

IQVIA Inc; Ernakulam; On-site; INR 600,000 - 900,000; Full time

Job summary

IQVIA Inc in India seeks a Clinical Database Designer responsible for study design, edit specifications and system configurations. You will collaborate with project stakeholders to ensure quality and timely delivery of design components, including eCRF design and rights/roles setup.

The role requires translating the study protocol into database design, generating specifications for EDC build components, attending design reviews, and documenting processes while adhering to SOPs.

Qualifications

• Bachelor's degree in science/CS/IT or BTech required.
• 0-2 years of relevant core Technical designer experience; total experience 5+ years required.

Responsibilities

• Interpret the study protocol.
• Design and update the eCRF.
• 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; present comments at Internal Design 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 for Entry and Updates.
• Communicate any project risks to the Data Team Lead, including potential timeline misses in the Data Management Project Plan.
• Escalate potential quality issues.
• Ensure completion and documentation of all project-specific training and staying current with SOPs.
• Reviews build timelines and provide input as applicable.

Skills

Study design

eCRF design

EDC build components

Quality assurance

Stakeholder collaboration

Education

Bachelor's degree in Science/Computer Science/Information Technology or B.Tech

Job description

Job Overview

Responsible for study design, edit specifications and system configurations. The Clinical database designer is accountable for associated quality and timely delivery of assigned study design components in collaboration with other project stakeholders.

Essential Functions

• Interprets the study protocol.


• Design and update the eCRF.


• 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.


• 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.


• 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


• 0-2 years of relevant core Technical designer experience and total exp being 5+ 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 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.