Remote Elixir/Phoenix Backend Engineer

Bluelight Consulting, Llc; Punta Arenas; A distancia; CLP 86.538.000 - 125.000.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a Centralized Monitoring Lead for LATAM, available for remote work. You will partner with project and clinical leads to ensure delivery aligns with contract objectives, while optimizing speed, quality, and cost in line with IQVIA SOPs.

You will oversee a global monitoring team, manage resources, and contribute to analytics strategies. Strong English communication, leadership, and regulatory knowledge are essential.

Formación

• Bachelor's degree in life sciences or related field.
• +3 years of relevant clinical monitoring experience (as remote or on site CRA). Advanced knowledge of clinical trial conduct and regulations (ICH GCP, local laws).
• +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.

Responsabilidades

• Lead Centralized Monitoring team and oversee clinical deliverables on global projects.
• Act as Unblinded Clinical Lead when needed and manage study IPs and related licenses.
• Manage project resources including CRAs and Central Monitors.
• Monitor study/site metrics and develop analytics strategy with senior team.
• Develop monitoring strategies, thresholds, and study management plans.
• Ensure documentation and eTMF quality for audits.
• Mentor junior staff.

Conocimientos

Leadership

Clinical monitoring

English fluency

Project management

Analytical thinking

Educación

Bachelor's degree in life sciences

Herramientas

eTMF

RBM tools

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

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

#LI-NRJ #LI-Remote

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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