Associate Centralized Monitor, Dutch speaking, South Africa

Job Summary

Provide project and study support to clinical teams by performing centralized monitoring, administrative tasks, data review, and system updates. Ensure all work aligns with SOPs, ICH-GCP, regulatory requirements, and project timelines.

Key Responsibilities

+ Complete required role training and follow all SOPs and quality standards.
+ Provide administrative support (run reports, maintain trackers, prepare status updates, follow up on outstanding items).
+ Update and maintain study systems and support compliance with project timelines.
+ Assist in preparing i-Site Packs and other study documents.
+ Perform centralized monitoring activities and assess site/data quality.
+ Monitor site performance metrics and follow up on missing data, queries, SDV backlog, and visit schedules.
+ Identify site-level risks and recommend/track corrective actions.
+ Conduct Subject Level Data Review (SLDR) and escalate issues as needed.
+ Perform ...