Data Acquisition Expert - EDC (Homebased, South Africa)

About the role

The EDC Data Acquisition Expert defines and implements Clinical Electronic Data Capture (EDC) tools and related documents and processes that meet the data capture requirements of the clinical trial protocol. The work is done in close collaboration with Data Managers, Study Responsible Physicians, Study Responsible Scientists and Biostatisticians. This is a home-based position in South Africa.

Key responsibilities

• Assess EDC collection requirements per protocol and create the study start-up eCRF package from global eCRF libraries.
• Design the eCRF layout including form dynamics, program edit checks and custom functions.
• Create and configure tSDV technical specifications, Safety Gateway integration specifications and datamart mapping specifications.
• Implement EDC coding configuration according to trial-defined coding requirements.
• Perform test and production Rave EDC migrations.
• Oversee planning, requirements and implementation of IWRS integrations into EDC.
• Serve as subject matter expert for complex elements of EDC database builds, including integrations and optimal custom functions.
• Train junior staff on the EDC build and migration process and tools.
• Take part in process, system and tool improvement initiatives within clinical data management.

Required profile

• At least 5 years of experience building EDC databases for clinical research.
• Demonstrated project management skills.
• Experience working in diverse, cross-functional, global and multiregional clinical research teams.
• Working knowledge of GCP/ICH guidelines.

Required skills

• Technical EDC build experience in Medidata Rave, including complex database builds.
• Advanced custom function programming knowledge.
• Experience on clinical trials.
• Knowledge of CDASH.