19054-Sr Central Monitor

Manage the execution of the assigned clinical studies from initiation through to closeout. Ensure that clinical study management and project deliverables are on time and is in accordance with standard operating procedures (SOPs), policies and practices. To provide project related support and assistance across multiple projects, sites, subjects and teams and review the structured clinical data output with access to analytical dashboards and apps. To ensure the work is conducted as per SOPs, Policies and Good clinical practice’s and applicable regulatory requirements. Adherence to protocol, overall completeness, and readiness of the supplied patient information to the next level of patient review and follow the metrics and timelines.
Facilitate efficient and effective review of multiple Reports from different sources and assure consistent standards of implementation for quality to meet or exceed quality standards. Ensure subject safety, data integrity, escalation of issues and timely and responsive feedback in compliance with IQVIA SOPs, (ICH GCP) guidelines, protocol requirements and regulatory compliance.
Develop and use of Data Analytics Plans (DAP) and/or risk-based monitoring specific tools and templates and/or other study specific plans to evaluate the quality and integrity of the study. Support project management team to identify ongoing risks and recommend monitoring strategies. 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.)

Required Skill sets:

• Understanding of Fundamentals of Statistics and its applications is essential.
• Basic knowledge of Risk Based Monitoring is a must.
• Understanding of Medical/ Clinical data is mandatory.
• Knowledge of different analytical tools; i.e.; Python, SPSS, R etc. is a plus, however not mandatory.
• Knowledge of SQL, Spot Fire, Machine Learning is a plus; yet, not mandatory.

Essential Functions
• Manage assigned studies under supervision.
• Attend study team meetings as needed or requested.
• Develop Project Management and Time Management Skills to deliver studies with more efficiency. Contribute to the development and use of Data Analytics plans and/or risk-based monitoring specific tools and templates and/or other study specific plans to evaluate the quality and integrity of the study.
• 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 centralized review & remote monitoring in the study and provide the inputs to relevant stakeholders. (CM-study)
• 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.
• In collaboration with data owners and functional managers, contribute to the development of data analysis and trend analysis methods
• 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.
• Escalate quality issues pertaining to site and/or subject to respective stakeholder within the project team.
• Early identification of site-level risk/issue(s) occurring during study conduct and responsible for identification of risk.
• Monitor site performance, subject safety and eligibility issues (overall) and make recommendations for timely corrective actions (e.g. Site Telephone Contact or Triggered Onsite Monitoring Visit).

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.