Clinical db designer

IQVIA India · Bengaluru, India

Job Title : Clinical DB Designer

Experience : 3 to 5

Location : Across PAN India (Hybrid)

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 e CRF.

• 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 (In Form)

• 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 In Form 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).