13 days ago
Remote, Poland or Warsaw, PolandMid 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 creation.
- Implement applicable functionality such as randomization, ePRO, IMP management, targeted SDV, and other non-core EDC features.
- Create study-level EDC documentation, including specifications, test plans, and study-specific training materials.
- Perform post-live EDC and reporting application changes under a change-control process.
- Work under the direction of the Director of Data Management and project-level oversight of the Project Data Manager.
Requirements
- Essential experience with Zelta v2.0.
- Prior experience creating EDC systems and programming edit checks.
- Graduate or bachelor’s degree in life sciences, pharma, or a related health discipline from an accredited institution.
- Proficiency with CDASH and SDTM data standards and their application to EDC system creation.
- Effective communication, collaboration, self-motivation, and ability to work independently.
- CDASH certification is preferred.
Benefits
- Full-time six-month contract.
- Position available at any of the employer’s European locations.
- Opportunity to contribute to clinical research and pharmaceutical treatments in a collaborative environment.
