11 hours ago
Remote, EMEAMid Level
Responsibilities
- Create EDC systems with study structures, workflows, edit checks, user roles, and permissions based on CDASH, study protocols, and eCRF templates.
- Configure applicable randomization, ePRO, IMP management, targeted SDV, and other non-core EDC functionality.
- Produce EDC specifications, test plans, and study-specific training materials.
- Perform post-live EDC and reporting-application changes under change control.
- Apply CDASH and SDTM data standards to EDC system creation.
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, pharma, or a related health discipline from an accredited institution.
- Proficiency with CDASH and SDTM data standards.
- CDASH certification is preferred.
- Effective communication, cooperation, self-motivation, and ability to work independently are required.
Benefits
- Collaborative work with clinical research, pharmacovigilance, and quality consulting experts.
- Opportunity to contribute to pharmaceutical research intended to improve patient care.
- Position 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.