日语中心化监查员

Essential Functions

● Manage assigned sites and perform Subject Level Data Review independently, if required perform with both responsibilities as dual role.;

● Perform remote monitoring visits for assigned sites as assigned.;

● Perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria/ IP/AE/ Labs/EOT/EOS/ End points/SAEs etc.) Review any other information as necessary to determine overall readiness of the patient information for next level review.;

● Perform Study specific analytics based on applicable study specific plans. Contribute in developing new analytics proposal as per customer's demand, Ability to write analytical inferences to add business value.;

● Manage the operational insight of the assigned sites/studies and complete the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.).;

● With guidance, provide Inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections.;

● Identify the value adds from the centralized review & remote monitoring in the study and provide the inputs to relevant stakeholders.;

● Support CMS leads to perform oversight on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operations Plan.;

● Collaborate and support project resources (CRAs/ CTAs/Centralized Monitoring team).;

● Ensure complete and accurate documentation of all the site-specific tools and templates and keep the sites audit ready.;

● Perform centralized monitoring activities on assigned sites and evaluate their quality and integrity as per the protocol, SOPs respective regulation and guidelines.;

● Ensure accurate completion and maintenance of internal systems, databases, tracking tools