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 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
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
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
