Remote Deployment Lead & Enterprise Integration Architect

Talent Connect Limited; Neuquén; A distancia; ARS 181.094.000 - 256.550.000; Jornada completa

Descripción de la vacante

Talent Connect is seeking a Centralized Monitoring Lead for LATAM with remote work. You will oversee the centralized monitoring team, partner with the project and clinical leads to deliver study objectives across multiple sites in LATAM, ensuring quality, speed, and compliance.

Responsibilities include leading the team, IP management, trend analysis, RBM tools, study management plans, mentoring junior staff, and attending client meetings to drive continuous process improvements.

Responsabilidades

• Lead the Centralized Monitoring team and oversee clinical deliverables per protocol and SOPs.
• Act as Unblinded Clinical Lead, manage IP and regulatory tasks.
• May serve as Clinical Lead on absence and project close-out.
• Manage project resources: CRAs, Central Monitors, CTAs, Centralized Monitoring Assistants.
• Monitor study/site metrics, trend analyses, action plans and compliance.
• Develop analytics strategy and advanced analytics.
• Support monitoring strategy with triggers/thresholds.
• Attend study team or client meetings.
• Provide inputs to study teams and stakeholders to drive improvements.
• Develop and maintain study management plans and RBM tools.
• Ensure documentation and eTMF readiness.
• Mentor or coach junior staff.

Descripción del empleo

Centralized Monitoring Lead in LATAM (Remote)

• Buenos Aires, Argentina
• Mexico City, Mexico
• Santiago, Chile
• Lima, Peru
• São Paulo, Brazil
• Bogota, Colombia
• Full time
• R

Job Overview

The Leader of the Centralized Monitoring team, partner with the project and clinical lead to achieve the delivery of the project's overall objectives to the sponsor's satisfaction per contract, while optimizing speed, quality and cost of delivery and in accordance with IQVIA SOPs, policies and practices.

Essential Functions

• Leadership activities:
• Leader of the Centralized Monitoring team, partner with the project and clinical lead to perform oversight on clinical deliverables on global assigned projects as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operations Plan.
• Unblinded Clinical Lead, including IP management for the assigned study to identify risk and proposed mitigation (including re-supply, re-labelling, Import/export licenses etc.)
• May act as Clinical Lead when there is not assigned to the study and at project close out.
• Manage project resources (CRAs/ Central Monitors/ Clinical Trial Assistants/ Centralized Monitoring Assistants)
• Analytical activities:
• Manage, monitor and complete 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 compliance etc.).
• Contribute to developing the study specific analytics strategy and work on developing advanced analytics.
• Support project management team to develop monitoring strategy, including monitoring triggers/thresholds.
• Attend study team and /or client meetings.
• Provide Inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections.
• Development and use of study management plans, and/or RBM specific tools and templates, and/or other study specific plans to evaluate the quality and integrity of the study.
• Ensure complete and accurate documentation of all the study specific tools and templates and keep the project Audit ready, including eTMF oversight.
• Mentors or coaches for junior staff.

Qualifications