Senior Clinical Data Architect - eCRF & SDTM Design

IQVIA; Bloemfontein; On-site; ZAR 600,000 - 900,000; Full time

Job summary

IQVIA in Bloemfontein, South Africa, seeks a Technical Designer to lead study build and design, and to edit specifications. You will collaborate with DTL, programmers, validation teams, vendors, statisticians, and client representatives.

Responsibilities include updating eCRF with CDMS tools aligned to SDTM/CDASH, creating Edit Specifications, and generating EDC build specifications. You will manage study design components and help with project timelines.

Qualifications

• Bachelor's Degree in Science/Computer Science/Information Technology or Technology
• 2–4 years of relevant core Technical designer experience and total exp being 7+ yrs.

Responsibilities

• Interpret the study protocol and design/update the eCRF using CDMS tools in alignment with SDTM/CDASH.
• Create and update Edit Specification Document.
• Generate specifications for EDC build components (e.g., Rights and Roles, System Settings).
• Attend and lead design review meetings and facilitate internal Edit Specification discussions.
• Design the database to collect LLRR data within the InForm database and ensure appropriate access rights.
• Communicate project risks to Data Team Lead and escalate quality issues.
• Identify areas for process improvements and contribute to SOPs.

Skills

Study design

SDTM/CDASH know-how

Stakeholder collaboration

Education

Bachelor's Degree in Science/Computer Science/Information Technology or Technology

Tools

CDMS tools

eCRF design tools

InForm database

Job description

IQVIA in Bloemfontein, South Africa, seeks a Technical Designer to lead study build and design, and to edit specifications. You will collaborate with DTL, programmers, validation teams, vendors, statisticians, and client representatives.

Responsibilities include updating eCRF with CDMS tools aligned to SDTM/CDASH, creating Edit Specifications, and generating EDC build specifications. You will manage study design components and help with project timelines.