At a Glance
- Tasks: Design and implement cutting-edge Clinical Electronic Data Capture tools for clinical trials.
- Company: Join a leading clinical research organisation with a focus on innovation.
- Benefits: Flexible home-based work, competitive salary, and opportunities for professional growth.
- Other info: Be part of a dynamic team driving improvements in clinical data management.
- Why this job: Make a real impact in clinical research while working with diverse global teams.
- Qualifications: 5+ years of EDC database building experience and strong project management skills.
The predicted salary is between 60000 - 80000 £ per year.
The EDC Data Acquisition Expert performs activities relating to the definition and implementation of Clinical Electronic Data Capture tools (EDC) and related documents and processes aligned with Clinical Trial Protocol defined requirements for data capture.
Activities are performed in close collaboration with Data Managers, Study Responsible Physicians (SRP), Study Responsible Scientists (SRS), and Biostatisticians.
Responsibilities
- Assess EDC collection requirements per protocol and create study start-up e CRF package based on global e CRF libraries.
- Design e CRF layout including form dynamics.
- Program Edit check and Custom Function.
- Create and configure t SDV 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.
Requirements
- 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.
- Experience working in highly diverse teams within clinical research; cross-functional, global, multiregional.
- Working knowledge of GCP/ICH guidelines.
- Knowledge of CDASH.
This role is not eligible for UK visa sponsorship.
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We think you need these skills to ace Data Acquisition Expert - EDC (Homebased UK/South Africa) in Reading
Clinical Electronic Data Capture (EDC)
eCRF Design
Edit Check Programming
Custom Functions Programming
tSDV Technical Specifications
Safety Gateway Integration
Datamart Mapping Specifications
