Senior EDC Data Acquisition Specialist - Medidata Rave

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

Job summary

IQVIA is seeking an EDC Data Acquisition Expert to define and implement Clinical Electronic Data Capture tools per protocol requirements. You will collaborate with Data Managers, SRPs, SRS, and Biostatisticians to build sophisticated EDC databases and support data integration across trials.

Responsibilities include start-up eCRF package creation, eCRF design, coding configurations, and IWRS/EDC integration planning.

Qualifications

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

Job description

IQVIA is seeking an EDC Data Acquisition Expert to define and implement Clinical Electronic Data Capture tools per protocol requirements. You will collaborate with Data Managers, SRPs, SRS, and Biostatisticians to build sophisticated EDC databases and support data integration across trials.

Responsibilities include start-up eCRF package creation, eCRF design, coding configurations, and IWRS/EDC integration planning.