11 hours ago
Remote, Spain or Madrid, SpainMid Level
Responsibilities
- Create EDC systems using study protocols, CDASH standards, and standard eCRF templates.
- Configure EDC structure, workflows, edit checks, and user roles and permissions.
- Implement applicable functionality including randomization, ePRO, IMP management, and targeted SDV.
- Create EDC specifications, test plans, and study-specific training materials.
- Perform post-live EDC and related reporting application changes 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, Pharma, 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, teamwork, self-motivation, and ability to work independently.
- CDASH certification is preferred.
Benefits
- Work on clinical research and pharmaceutical projects intended to improve patient treatment and safety.
- Join a collaborative, international organization with opportunities to contribute across countries, cultures, and time zones.
- The position is available in any of the company’s European locations.
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.