Senior EDC Data Acquisition Specialist

IQVIA; Livingston; In loco; GBP 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

IQVIA in United Kingdom is seeking an EDC Data Acquisition Expert to define and implement Clinical Electronic Data Capture tools and related processes aligned with trial requirements. You will collaborate with Data Managers, SRP/SRS, and Biostatisticians to build robust EDC databases using Medidata Rave, design eCRFs, implement edit checks, and oversee system integrations and migrations.

The role emphasizes training junior staff and contributing to process improvements within clinical data

Competenze

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

Mansioni

• 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 expert for complex elements of EDC database builds (including integrations).
• 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

Conoscenze

EDC databases

Medidata Rave

Project management

Advanced custom functions

Clinical trials

GCP/ICH

CDASH

Strumenti

Medidata Rave

Descrizione del lavoro

IQVIA in United Kingdom is seeking an EDC Data Acquisition Expert to define and implement Clinical Electronic Data Capture tools and related processes aligned with trial requirements. You will collaborate with Data Managers, SRP/SRS, and Biostatisticians to build robust EDC databases using Medidata Rave, design eCRFs, implement edit checks, and oversee system integrations and migrations.

The role emphasizes training junior staff and contributing to process improvements within clinical data