Job Role - Sr Clinical Database Designer.

Education required - Any graduates.

Experience range - 4 to 10 years.

Work Location - Pan India.

Work Mode - Remote.

Skills Required - Robust experience in CRF design, protocol interpretation, startup activities.

Job Overview

Responsible for study build & design, edit specifications, system configurations and is accountable for associated study design components. This role will collaborate with various stakeholders- DTL, Programmer, Validation Team, vendors, statisticians, and client representatives. In addition to project deliveries, the role also would be responsible for the project financials from programming shared services perspective.

Essential Functions

- Interprets the study protocol.
- Design and update the eCRF using third party or in house CDMS tools in alignment with industry standards like SDTM, CDASH as applicable.
- 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. May lead Online Screen 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.
- Reviews QIP for own projects, identify out of scope activities if any and inform relevant parties.
- Responsible for multiple study design projects at the same time.
- Might be working on projects across multiple platforms.
- Identify areas for process improvements on an ongoing basis. Actively take part and contribute towards process improvement initiatives as assigned besides providing suggestions for continuous improvement of processes.
- All responsibilities are essential job functions unless noted as nonessential (N).

📌 Senior Clinical Database Designer (Bengaluru)
🏢 Iqvia
📍 Bengaluru