Adobe Multiplatform Specialist - Work From Home

Nortal

Tandil

A distancia

ARS 137.587.000 - 198.737.000

Jornada completa

Hace 5 días
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Descripción de la vacante

Nortal is seeking a Centralized Monitoring Lead in LATAM for a remote role spanning multiple countries. You will partner with project and clinical leads to ensure delivery aligned with contracts, while optimizing speed, quality and cost under IQVIA SOPs.

The role focuses on leading a distributed team of CRAs and central monitors, guiding risk mitigation, RBM tools, and analytics; you will mentor staff and participate in client meetings.

Formación

  • Bachelor's degree in life sciences or related field.
  • +3 years of relevant clinical monitoring experience (remote or on-site).
  • +2 years in a Lead role.
  • Strong English written and verbal communication (Mandatory).
  • Excellent organizational, problem solving and decision making skills.
  • Ability to lead and work effectively in a global, multi-country team.
  • Ability to manage multiple projects and priorities.

Responsabilidades

  • Lead the Centralized Monitoring team and oversee clinical deliverables.
  • Identify risks and propose mitigations across studies.
  • Act as Clinical Lead when needed and manage project resources.
  • Develop monitoring strategies and RBM tools with the project team.
  • Monitor study/site metrics and ensure compliance with ICH GCP.
  • Mentor junior staff and contribute to continuous process improvements.

Conocimientos

English Proficiency
Leadership
Clinical Monitoring
Project Management
Stakeholder Communication
Analytical Thinking
Team Mentoring
Time 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.

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