Senior EDC Architect: Medidata Rave Global Clinical Trials

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

Job summary

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence. The EDC Data Acquisition Expert role focuses on defining and implementing EDC tools in alignment with trial protocols, collaborating with Data Managers, SRPs, SRSs and Biostatisticians.

You will design eCRF layouts, configure custom functions, and oversee EDC integration efforts, including IWRS and Rave migrations.

Qualifications

• Minimum of 5 years' experience building EDC databases in support of 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 highly diverse teams within clinical research; cross-functional, global, multiregional.
• 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 check and Custom Function.
• 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 design

Clinical data management

Project management

Advanced custom function programming

GCP/ICH knowledge

CDASH

Cross-functional collaboration

Global multiregional teams

Tools

Medidata Rave

Rave integration

Job description

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence. The EDC Data Acquisition Expert role focuses on defining and implementing EDC tools in alignment with trial protocols, collaborating with Data Managers, SRPs, SRSs and Biostatisticians.

You will design eCRF layouts, configure custom functions, and oversee EDC integration efforts, including IWRS and Rave migrations.