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AI Summary
Manage clinical study systems and documentation while supporting the Project Lead in day-to-day coordination. Responsible for data review, generating study reports, and coordinating communications across study teams.
Key Responsibilities
- Manage clinical study systems (CTMS, IWRS, EDC) and user access.
- Maintain study documentation, including eTMF management and filing.
- Act as a support to the Project Lead, assisting with day-to-day study coordination and any ad hoc requests from the study teams.
- Support data review activities and follow up with CRAs on outstanding issues.
- Generate study reports and track study metrics as required.
- Coordinate internal and external communications across study teams.
- Support study operations, including payments (sites/vendors), system setup, and compliance tracking.
Requirements
- Minimum 2 years’ experience in clinical research.
- Good knowledge of ICH-GCP and applicable regulatory requirements.
- Strong organisational skills and attention to detail.
- Effective communication and ability to work collaboratively.
- Proficiency in MS Office and clinical systems/tools.
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