13 days ago
Remote, Czechia or Prague, CzechiaMid Level
Responsibilities
- Create EDC systems for complex projects, including structure, workflows, edit checks, and user roles and permissions.
- Apply CDASH standards, study protocols, and standard eCRF templates to EDC system development.
- Configure applicable functionality such as randomization, ePRO, IMP management, targeted SDV, and other non-core EDC features.
- Create EDC specifications, test plans, study-specific training materials, and other study-level documentation.
- Perform post-live EDC and applicable reporting-application changes under change control.
- Work under the direction of the Director of Data Management and project-level oversight of the Project Data Manager.
Requirements
- Graduate or bachelor's degree in life sciences, pharmaceutical sciences, or a related health discipline from an accredited university or college.
- Essential experience with Zelta v2.0.
- Prior experience creating EDC systems and programming edit checks.
- Proficiency in applying CDASH and SDTM data standards to EDC system creation.
- Effective communication skills and a cooperative, team-oriented approach.
- Self-motivation and the ability to work independently.
- CDASH certification is preferred.
Benefits
- Full-time six-month contract.
- Position available at any Ergomed European location.
- Collaborative work with experts in clinical research, pharmacovigilance, and quality consulting.
Categories
