– Perform data discrepancy management– Execute data review per defined guidelines (e.g. SAE reconciliation, Third Party Data reconciliation, STATS checks etc.)– Knowledgeable of study protocol to provide feedback to PDM on consistency and completeness of clinical database/study design
– Perform data discrepancy management– Execute data review per defined guidelines (e.g. SAE reconciliation, Third Party Data reconciliation, STATS checks etc.)– Knowledgeable of study protocol to provide feedback to PDM on consistency and completeness of clinical database/study design
– Communicate any risk and issues to PDM– Send required reports to PDM on set frequencies– Update CPT on a regular defined frequency– Create/Update issue logs on ongoing basis– Sticky note acknowledgement in Rave for studies with Paper component– Upload processed documents on applicable Sharepoint– Manage assigned activities to meet milestone dates– Ask questions to get information needed to meet end goals
– Communicate any risk and issues to PDM– Send required reports to PDM on set frequencies– Update CPT on a regular defined frequency– Create/Update issue logs on ongoing basis– Sticky note acknowledgement in Rave for studies with Paper component– Upload processed documents on applicable Sharepoint– Manage assigned activities to meet milestone dates– Ask questions to get information needed to meet end goals