Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
Oversees site interactions post‑activation through site closeout, including patient recruitment, investigator payments, or related activities.
Identifies critical data and process, protocol execution risks and risk mitigations related to the Risk Assessment and Categorization Tool (RACT).
Reviews study scope of work, budget and protocol content to ensure the clinical project team (CRAs/Central Monitors) is aware of contractual obligations and parameters.
Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
Escalates risks to the project manager regarding timeline, quality and budget, and activities outsid...