Clinical Database Designer

Role : Clinical database designer

Work Experience : 2-5+ Years.

Work location : Kochi / Kolkata / Bangalore / Thane / Hyderabad

Work Mode : Hybrid

Must Have Skills : Protocol interpretation, Design the eCRF, Create and update Edit Specification

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
• 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.

Qualifications :

Skills Required

Unblinded Data review meeting, Design the database to collect LLRR data, Online Screen Review Meeting, Create and update Edit Specification, Complete the Study Authorization Form, Design the eCRF, Trial Capacity Request Form InForm, Generate specifications for EDC build components, Protocol interpretation, Ensure Rights and Roles document has appropriate access