11 hours ago
Remote, EMEA or Warsaw, PolandMid Level
Responsibilities
- Create EDC systems for complex projects using study protocols, CDASH standards, and standard eCRF templates.
- Configure EDC structures, workflows, edit checks, user roles, and permissions.
- Implement applicable randomization, ePRO, IMP management, targeted SDV, and other non-core EDC functionality.
- Create EDC specifications, test plans, study-specific training materials, and other study-level documentation.
- Perform post-live changes to EDC systems and related reporting applications under change control.
Requirements
- Essential experience with Medidata RAVE and Zelta v1.0.
- Graduate or bachelor’s degree in Life Sciences, Pharma, or a related health discipline from an accredited university or college.
- Prior experience creating EDC systems and programming edit checks.
- Proficiency with CDASH and SDTM data standards and their application to EDC system creation.
- Effective communication, cooperation, teamwork, self-motivation, and ability to work independently.
- CDASH Certification is preferred.
Benefits
- The position is available in any of the company’s European locations.
- Join a collaborative clinical research, pharmacovigilance, and quality consulting organization focused on improving patient treatment.
Categories
About Ergomed
Ergomed is a contract research and pharmacovigilance services provider for pharmaceutical, biotechnology, and medical device companies. It delivers outsourced clinical development, data management (including EDC build), safety monitoring, and regulatory compliance, notably through its PrimeVigilance business. The company is privately held, operates globally, and is headquartered in Guildford, Surrey.