Clinical Database Designer

Role:

Work Experience

Work location

Work Mode:

Must Have Skills:

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:

• Bachelor's Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology Req