Remote Centralized Monitoring Lead (LATAM)

Blacksmith Agency LLC; La Pampa; A distancia; ARS 137.157.000 - 182.877.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a Centralized Monitoring Lead for LATAM to work remotely across Argentina, Brazil, Peru, Colombia and other LATAM regions. You will partner with project and clinical leads to drive delivery per contract while optimizing speed, quality and cost in accordance with IQVIA SOPs.

The role leads the Centralized Monitoring team, overseeing clinical deliverables, identifying risks, and implementing mitigations.

Formación

• Bachelor's degree in life sciences or related field.

Responsabilidades

• 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)
• 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.

Educación

Bachelor's degree in life sciences or related field

Descripción del empleo

IQVIA is seeking a Centralized Monitoring Lead for LATAM to work remotely across Argentina, Brazil, Peru, Colombia and other LATAM regions. You will partner with project and clinical leads to drive delivery per contract while optimizing speed, quality and cost in accordance with IQVIA SOPs.

The role leads the Centralized Monitoring team, overseeing clinical deliverables, identifying risks, and implementing mitigations.