Remote Centralized Monitoring Lead - LATAM

Basta & Company; Buenos Aires; A distancia; ARS 137.157.000 - 198.116.000; Jornada completa

Descripción de la vacante

IQVIA seeks a Centralized Monitoring Lead for LATAM with remote capabilities across Argentina, Brazil, Peru, Colombia, and beyond. You will lead the Centralized Monitoring team, align with project and clinical leads to meet contract objectives, and optimize speed, quality and cost of delivery in line with IQVIA SOPs.

The role drives monitoring strategy, oversees study metrics, mentors staff, and collaborates with global teams. Fluent English is mandatory; remote work is offered across LATAM.

Formación

• +3 years of relevant clinical monitoring experience (as remote or on site CRA). Advanced knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.
• +2 years in a Lead role.
• Strong written and verbal communication skills including advanced command of English (Mandatory).
• Strong organizational, problem solving and decision making skills.
• Results and detail-oriented approach to work delivery and output.
• Excellent motivational, influencing, negotiating and coaching skills.
• Ability to work on multiple global projects and manage competing priorities.
• To lead team and effectively work in team.

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.

Conocimientos

Remote monitoring

Lead role experience

English proficiency

Project management

Communication skills

Educación

Bachelor's degree in life sciences or related field

Descripción del empleo

IQVIA seeks a Centralized Monitoring Lead for LATAM with remote capabilities across Argentina, Brazil, Peru, Colombia, and beyond. You will lead the Centralized Monitoring team, align with project and clinical leads to meet contract objectives, and optimize speed, quality and cost of delivery in line with IQVIA SOPs.

The role drives monitoring strategy, oversees study metrics, mentors staff, and collaborates with global teams. Fluent English is mandatory; remote work is offered across LATAM.