Docs Global (Continental Europe)

EDC (RAVE) Systems Analyst, Manager

United Kingdom
22 Feb 2021
03 Mar 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Title: EDC (RAVE) Systems Analyst / Manager
Duration: Full Time Permanent Employment
Location: UK or Europe

- Provide Project Management guidance to study teams, study startup and closeout guidance, migration support, tracking high‐level study milestone information and clinical view refreshes when required in the Electronic Data Capture (EDC) Tool.
- Support continuous improvement framework with respect to systems deployment, project management and enhancements supported by greater partnerships with suppliers, CRO partners and industry user groups.
- Support in systems inspection readiness and provide expertise as necessary for FDA and other health authority inspections.
- Supporting study teams with scheduling migrations; Maintaining the Trial Data Repository in Medidata Rave
- Manage Database lock activities such as updating user access, clinical view (CV) refreshes and also database un‐lock & archival activities
- Uploading eCRF guidelines on the FTP server and granting user access to iMedidata and Medidata Rave
- Guide study team members to Data Collection Solutions documentation; Review listings and follow‐up with study team members as appropriate
- Participate in UAT activities of system upgrades; Assist with vendor management
- Excellent problem solving and decision‐making skills; Strong planning, organization and project management skills
- Contribute to the Data Collection Solutions team in the development, implementation, maintenance and continuous improvement of systems.

Education and Experience Requirements:
• Bachelor's degree in Engineering, Science, or Computer Science is preferred.
• Minimum of 3 years of experience working within systems covering clinical development in the Pharma sector.
• Knowledge of Electronic Data Capture (EDC) systems with strong working knowledge of iMedidata and Rave.
• Strong communication skills with Attention to detail
• Understanding of GCP, ICH guidelines and 21 CFR part 11

What we offer:
- 100% home based (in UK or some European countries)
- Full-time permanent roles
- Opportunities to be part of a TOP 10 CRO and working on Secondment for a TOP Pharma company - working to their processes, SOPs and on their systems.
- Competitive compensation package
- Flexible working hours