EDC Data Specialist — Medidata Rave & Clinical Trials

IQVIA; Bellville (TX); Sur place; USD 86 000 - 119 000; Plein temps

Résumé du poste

IQVIA is seeking an EDC Data Acquisition Expert to define and implement Clinical Electronic Data Capture tools and processes in line with trial protocols. You will work closely with Data Managers, SRP, SRS and Biostatisticians to build robust eCRF structures and supporting documentation.

Responsibilities include designing eCRF layouts, coding configurations, eCRF migrations, IWRS integrations, and SME guidance on complex EDC builds.

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 and in diverse global teams.
• Working knowledge of GCP/ICH guidelines.

Responsabilités

• 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

Connaissances

EDC database development

Medidata Rave

Project management

Custom functions programming

GCP/ICH knowledge

Outils

Medidata Rave

Description du poste

IQVIA is seeking an EDC Data Acquisition Expert to define and implement Clinical Electronic Data Capture tools and processes in line with trial protocols. You will work closely with Data Managers, SRP, SRS and Biostatisticians to build robust eCRF structures and supporting documentation.

Responsibilities include designing eCRF layouts, coding configurations, eCRF migrations, IWRS integrations, and SME guidance on complex EDC builds.