7 hours ago
Remote, EMEAMid Level
Responsibilities
- Create EDC systems for complex projects, including structures, workflows, edit checks, user roles, and permissions.
- Apply CDASH standards, study protocols, and standard eCRF templates to EDC system creation.
- Configure 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 applicable reporting applications under change control.
Requirements
- Essential experience with Medidata RAVE and Zelta v1.0.
- Prior experience creating EDC systems and programming edit checks.
- Graduate or bachelor's degree in life sciences, pharmaceutical sciences, or a related health discipline from an accredited institution.
- Proficiency in CDASH and SDTM data standards and their application to EDC system creation.
- Effective communication, cooperation, self-motivation, and the ability to work independently.
- CDASH certification is preferred.
Benefits
- Work with collaborative clinical research, pharmacovigilance, and quality consulting professionals supporting pharmaceutical development.
- The position is available in any of the company's European locations.
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.