EDC Data Architect & Rave Expert

IQVIA; Bloemfontein; On-site; ZAR 900,000 - 1,300,000; Full time

Job summary

IQVIA in Bloemfontein seeks an EDC Data Acquisition Expert to define and implement electronic data capture tools for clinical trials, collaborating with Data Managers, SRP, SRS and Biostatisticians. You will design eCRF layouts, program edit checks and functions, configure technical specs, and support IWRS integrations.

The role focuses on complex EDC builds and CDASH/GCP adherence. Applicants should have 5+ years of EDC database experience, Medidata Rave expertise, proven PM skills, and

Qualifications

• 5+ years’ experience building EDC databases in clinical research.
• Technical EDC build experience in Medidata Rave implementing complex database builds.
• Demonstrated project management skills.
• Advanced custom functions programming knowledge.
• Experience working on clinical trials.
• Experience working in diverse, global, multiregional teams.
• Working knowledge of GCP/ICH guidelines.
• Knowledge of CDASH.

Responsibilities

• Assess EDC collection requirements per protocol and create study start-up eCRF package based on global eCRF libraries.
• Design eCRF layout including form dynamics.
• Program Edit checks and Custom Functions.
• Create and configure tSDV technical specifications, Safety Gateway integration specifications and Datamart mapping specifications.
• Implement EDC coding configuration based on trial defined coding requirements.
• Perform test and Prod Rave EDC Migration
• Oversee planning, requirements, and implementation of IWRS integrations to EDC.
• Serve as subject matter expertise for complex elements of EDC database builds (including integrations).
• Serve subject matter expertise for complex elements of EDC database builds (including optimal custom functions implementation).
• Provide training to junior staff on EDC build and migration process and Tools
• Participate in process, system, and tool improvement initiatives within clinical data management

Skills

EDC database development

Medidata Rave

Project management

Advanced custom functions

Clinical trials experience

Cross-functional collaboration

CDASH knowledge

GCP/ICH knowledge

Tools

Medidata Rave

IWRS integrations

Job description

IQVIA in Bloemfontein seeks an EDC Data Acquisition Expert to define and implement electronic data capture tools for clinical trials, collaborating with Data Managers, SRP, SRS and Biostatisticians. You will design eCRF layouts, program edit checks and functions, configure technical specs, and support IWRS integrations.

The role focuses on complex EDC builds and CDASH/GCP adherence. Applicants should have 5+ years of EDC database experience, Medidata Rave expertise, proven PM skills, and