Centralized Monitor (R1100548) in Shanghai, China at IQVIA™

Date Posted: 10/25/2019

Job Snapshot

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Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics 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 re-supply, 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)
• Participate in (study) team meetings/Project kick off meetings and interaction with cross functional staff to verify information and/or triage new data issues or prior identified action items

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

Job ID: R1100548