Senior Clinical Database Designer

About the role

iQVIA is looking for a Senior Clinical Database Designer in Bloemfontein. The role covers study build and design, edit specifications and system configurations, and works with stakeholders such as the DTL, programmer, validation team, vendors, statisticians and client representatives. It also includes responsibility for project financials from a programming shared services perspective.

Key responsibilities

• Interpret the study protocol and design and update the eCRF using third-party or in-house CDMS tools in line with industry standards such as SDTM and CDASH.
• Create and update the Edit Specification Document and generate specifications for EDC build components (Rights and Roles, System Settings, Home Page).
• Complete the Study Authorization Form and Trial Capacity Request Form (InForm).
• Attend pre-design, online screen review, unblinded data review and internal design review meetings, and may lead the online screen review meeting.
• Facilitate the internal Edit Specification review meeting and design the database to collect LLRR data in the InForm database with appropriate rights and roles.
• Communicate project risks to the Data Team Lead, escalate quality issues, and review build timelines and QIPs.
• Ensure project-specific training and SOPs are completed and documented, and work on several study design projects at once, possibly across multiple platforms.
• Identify and contribute to process improvements.

Required profile

• Bachelor's degree in Science, Computer Science, Information Technology or Technology.
• 2-4 years of relevant core technical designer experience, with a total of 7+ years of experience.