Senior Mechanical Engineer

Arup; Lima Metropolitana; A distancia; PEN 375.000 - 579.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a Centralized Monitoring Lead in LATAM for a remote, full-time role. Lead the Centralized Monitoring team, ensure quality and timely delivery, and collaborate with global project teams to optimize monitoring strategies and RBM tools.

The candidate will manage resources, provide strategic analytics input, and mentor junior staff while ensuring compliance with ICH GCP and local regulations.

Formación

• Bachelor's degree in life sciences or related field.
• +3 years of relevant clinical monitoring experience (remote or on-site CRA). Advanced knowledge of clinical trial conduct and regulatory requirements (ICH GCP).
• +2 years in a Lead role.
• Strong written and verbal communication skills including advanced English (Mandatory).
• Strong organizational, problem solving and decision making skills.

Responsabilidades

• Lead the Centralized Monitoring team and oversee clinical deliverables across global projects.
• Act as Unblinded Clinical Lead and manage IP for assigned studies, identifying risks and mitigations.
• Potentially serve as Clinical Lead when not assigned, and manage project resources.
• Develop and monitor study metrics, contribute to analytics strategy, and support monitoring strategy.
• Attend study team or client meetings and provide input to decision makers.
• Mentor or coach junior staff and ensure RBM tools/templates are used correctly.

Conocimientos

Leadership experience

Excellent English

Communication skills

Educación

Bachelor's degree in life sciences

Descripción del empleo

Centralized Monitoring Lead in LATAM (Remote)

IQVIA

Hoy

• 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.

EEO Minorities/Females/Protected Veterans/Disabled