10 hours ago
Guildford, United KingdomMid Level
Responsibilities
- Create EDC systems for complex projects, including structure, workflows, edit checks, and user roles and permissions.
- Configure 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 training materials.
- Perform post-live changes to EDC systems and related reporting applications under change control.
- Apply CDASH data standards, study protocols, and standard eCRF templates 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, pharmaceutical sciences, 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, cooperation, teamwork, self-motivation, and ability to work independently.
- CDASH certification is preferred.
Benefits
- Collaborative, diverse, and inclusive work environment focused on clinical research and improving patient outcomes.
- Position available at 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.