Sr Clinical DB Designer

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

Job summary

IQVIA in India seeks a Clinical Database Designer to drive study design, edit specifications, and system configurations, ensuring quality and timely delivery in collaboration with project stakeholders.

You will design databases, update Edit Specifications, and contribute to EDC component specifications. The role requires interpreting protocols and attending meetings to align on project goals and timelines.

Qualifications

• 0-2 years of relevant core technical designer experience
• Total experience 5+ years required

Responsibilities

• 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 various design and review meetings and present comments.
• Facilitate internal Edit Specification Review meetings and lead discussions.
• Design the database to collect LLRR data within the InForm database and ensure access controls.
• Communicate project risks to Data Team Lead and escalate quality issues.
• Ensure training completion and adherence to SOPs.

Skills

Technical design experience

Communication

Education

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

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.

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.