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Centralized Study Analyst @ Fortrea

SofiaOnsiteFull-time
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About this role

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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