IQIqvia Biotech
Clinical DB Designer
Cochin / Kochi / Ernakulam ₹5-8 LPA Posted 25 Jun 2025
FULL TIME
clinical database setup
eCRF design
EDC build (InForm)
edit check specification
protocol interpretation
+1 more
Job Description
- 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
- Bachelors Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology Req