Mobile Engineering Manager: Lead Ios & Android Delivery

Epam Systems, Inc.; La Pampa; A distancia; ARS 91.438.000 - 137.157.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a Centralized Monitoring Lead for LATAM with remote work options. The role partners with project and clinical leads to deliver objectives per contract, optimizing speed, quality, and cost in accordance with IQVIA SOPs. You will oversee a team, manage risks, and contribute to analytics across global projects.

The ideal candidate has 3+ years in clinical monitoring, 2+ years in a lead role, strong English skills, and proven leadership, organizational, and coaching abilities.

Formación

• +3 years of relevant clinical monitoring experience (remote or on site)
• +2 years in a Lead role
• Advanced knowledge of ICH GCP and relevant local regulations
• Fluent English (Mandatory)
• Strong organizational, problem solving and decision making skills
• Ability to work on multiple global projects and manage priorities
• Mentors or coaches for junior staff

Responsabilidades

• Oversee the Centralized Monitoring team and ensure delivery per protocol and SOPs
• Act as Unblinded Clinical Lead and manage IP and risk mitigations
• May act as Clinical Lead when not assigned to the study and at project close out
• Manage project resources (CRAs/ Central Monitors/ Clinical Trial Assistants/ Centralized Monitoring Assistants)
• Monitor study/site metrics, trend analysis, and action plans
• Develop monitoring strategy, RBM tools and templates, and study-specific plans
• Ensure documentation and audit readiness (eTMF oversight)
• Provide inputs to study teams and stakeholders to drive process improvements

Conocimientos

Leadership

Communication

Problem solving

Coaching

Team management

Educación

Bachelor's degree in life sciences

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.

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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