Senior EDC Data Architect — Medidata Rave Expert

IQVIA; United States; Remote; USD 110,000 - 160,000; Full time

Job summary

IQVIA is seeking an EDC Data Acquisition Expert to define and implement Clinical Electronic Data Capture tools in alignment with trial protocols. You will collaborate with Data Managers, SRP, SRS, and Biostatisticians to ensure high-quality data capture and compliant processes.

Role demands 5+ years building EDC databases, strong Medidata Rave experience, advanced custom functions, and proven PM skills in global, cross-functional settings.

Qualifications

• Minimum 5 years’ experience building EDC databases in clinical research.
• Advanced Custom Functions programming knowledge.
• Demonstrated project management skills.
• Experience with clinical trials and cross-functional, global teams.
• GCP/ICH knowledge and CDASH familiarity.

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

Tools

Medidata Rave

Job description

IQVIA is seeking an EDC Data Acquisition Expert to define and implement Clinical Electronic Data Capture tools in alignment with trial protocols. You will collaborate with Data Managers, SRP, SRS, and Biostatisticians to ensure high-quality data capture and compliant processes.

Role demands 5+ years building EDC databases, strong Medidata Rave experience, advanced custom functions, and proven PM skills in global, cross-functional settings.