Centralized Monitor (R1058196)

Job Description

Join us on our exciting journey!IQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

• Manage assigned studies with minimal supervision.
• Attend study team meetings as needed or requested.
• Contribute to the development and use of study management plans and/or DTE specific tools and templates and/or other study specific plans to evaluate the quality and integrity of the study.
• Support project management team to develop monitoring strategy including monitoring triggers/thresholds.
• Manage the operational insight of the assigned project(s) 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.)
• Contribute to developing the study specific analytics strategy and/or work on developing advanced analytics.
• 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 medical review & remote monitoring in the study and provide the inputs to relevant stakeholders.
• Support CL to perform oversight on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operations Plan.
• Manage project resources (CRAs/ CTAs/Centralized Monitoring team).
• Perform the IP management for the assigned study to identify risk and proposed mitigation (including resupply, re-labelling, Import/export licenses etc.).
• Ensure complete and accurate documentation of all the study specific tools and templates and keep the project audit ready.
• Perform centralized monitoring activities on assigned projects and evaluate the quality and integrity of the
  study as per the protocol, SOPs respective regulation and guidelines.
• Ensure accurate completion and maintenance of internal systems, databases, tracking tools/reports for the project specific information.
• Perform Management of triggers and preparation of i-site pack for respective sites and countries for assigned study(ies).
• In collaboration with data owners and functional managers, contribute to development of data analysis methods and procedures for mining study data; performing the trend analytics for their respective study(ies)

We know that meaningful results require not only the right approach but alsothe right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA

Job ID: R1058196