Associate Centralized Monitoring Lead

Job title: Associate Centralized Monitoring Lead

About the Role The Associate Centralized Monitoring Lead provides support to CMS leads on activities related to the CMS team, in partnership with project and clinical leads, and in collaboration with other functional teams, to achieve the delivery of the project’s objectives to sponsor satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with IQVIA SOPs, policies and practices. The role focuses on supporting the centralized team functionally and addressing clinical risks identified, implementing strategies to address those issues, ensuring subject safety, data integrity, escalation of issues, and timely feedback in compliance with IQVIA SOPs, ICH/GCP guidelines, protocol requirements, and regulatory compliance. It includes review of the Study Central Monitoring Plan.

What You'll Do

• Provide support to CMS leads on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operation Plan (COP) from Applications/ Analytics/ Therapeutics/ Quality perspective.
• May perform functional lead responsibilities for assigned project deliverables for certain smaller or less complex projects from start-up to final deliverables including closeout.
• Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested and note CMS specific action items.
• Support CMS Lead to oversee the Finance related information in the study and provide inputs to EAC.
• May manage Investigator Payment Activity from set up to close out of the study.
• Contribute to the development and use of study management plans including Risk Assessment and Mitigation Plan, specific tools and document templates and/or other study specific plans to evaluate the quality and integrity of the study, including complete and accurate documentation so that the project is audit ready.
• Support CMS Lead/project team to develop monitoring strategy including monitoring triggers/thresholds, and the study specific analytics strategy, work on developing analytics based on applicable study specific plans, develop new analytics proposal as per customers demand, Perform quality reviews on the analytical output created by the team members.
• Manage operational insight of the assigned project(s) and perform the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and discuss the action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.).
• Provide Inputs to CMS Lead/Project team, key decision makers, and internal team members to manage continuous process improvement.

What We're Looking For

• Experience supporting CMS activities and centralized monitoring in clinical trial settings.
• Knowledge of ICH/GCP guidelines, SOPs, COP, and regulatory requirements.
• Ability to develop monitoring strategies and analytics, and to review analytical outputs.
• Strong attention to detail, audit-readiness, and ability to coordinate with project teams and clients.
• Experience with Investigator Payments and finance-related study information is a plus.
• Strong communication skills and ability to attend and document meetings.

Compensation & Benefits

• Not disclosed in the posting.