7 hours ago
Remote, United KingdomSenior
Responsibilities
- Create and maintain CDASH-compliant eCRF template libraries and supplementary documentation.
- Configure and review EDC systems for structure, workflows, edit checks, user roles, and permissions based on protocols, data standards, and templates.
- Provide technical oversight, training, support, and guidance to sponsors and clinical, business development, and study teams.
- Support system validation activities, documentation, gap analyses, post-live changes, and study-level EDC documentation.
- Use SAS, SQL, Python, and Power BI to create data listings, reports, quality checks, dashboards, and metrics.
- Oversee data migrations and coordinate with external vendors on transferred and imported data formats and mechanisms.
- Manage coding dictionary updates and support coding processes involving WHO Drug and MedDRA.
- Oversee site and user account management, record maintenance, and periodic reviews.
Requirements
- Experience with Medidata RAVE and Zelta v1.0 is essential.
- Graduate or bachelor’s degree in life sciences, pharmaceutical sciences, or a related health discipline from an accredited institution.
- Advanced proficiency in data systems and accreditation in at least one clinical trial EDC system.
- Experience creating EDC systems and programming edit checks.
- Proficiency with CDASH and SDTM data standards and their application to EDC creation.
- CDASH certification is preferred.
- Effective communication, collaboration, self-motivation, and ability to work independently are required.
Benefits
- Collaborative work with experts in clinical research, pharmacovigilance, and quality consulting.
- The position is available in any of the company’s European locations.
- Inclusive culture emphasizing quality, integrity, belonging, collaboration, and professional growth.
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.