Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
Responsibilities
Oversee site interactions post activation through site closeout
Identify critical data and process risks
Review study scope, budget and protocol content
Escalate risks to project manager
Propose and implement risk mitigations
Requirements
Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Clinical Trial Manager II responsible for site management oversight, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance, and data integrity.
Locations (5)
Brazil
Argentina
Mexico
Chile
Peru
Responsibilities
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. This may include patient recruitment, investigator payments or other related activities.
May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters.
Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
Requirements
Bachelor’s degree or RN in related field or equivalent combination of education, experience