IQ

Clinical DB Designer

Iqvia Biotech
Cochin / Kochi / Ernakulam5-8 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
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