Senior Bi Product Manager — Remote, Finance Data & Ai

Agileengine; Neuquén; A distancia; ARS 137.587.000 - 198.737.000; Jornada completa

Descripción de la vacante

AgileEngine seeks a Centralized Monitoring Lead for LATAM on a remote basis. You will partner with project and clinical leads to achieve project objectives, while aligning with IQVIA SOPs and regulatory requirements.

Lead the Centralized Monitoring team, manage resources, develop analytics strategies, monitor study metrics, and ensure study documentation and audit readiness across global projects. Proficiency in English is mandatory.

Formación

• Bachelor's degree in life sciences or related field.
• +3 years of relevant clinical monitoring experience (remote or on site CRA) with knowledge of ICH GCP and local regulations.
• +2 years in a Lead role.
• Strong command of English (mandatory).
• Strong organizational and decision-making skills; ability to manage multiple global projects.
• Excellent motivational and coaching skills.

Responsabilidades

• Lead the Centralized Monitoring team and oversee deliverables per protocol and SOPs.
• Unblinded Clinical Lead responsibilities including IP management and risk mitigation.
• Manage project resources (CRAs, Central Monitors, CAs) and coordinate across global projects.
• Develop analytics strategy and monitoring triggers/thresholds.
• Attend study team and client meetings; provide inputs to key decision makers.
• Ensure study tools/templates are documented and audit-ready; RBM oversight.
• Mentor or coach junior staff.

Conocimientos

Leadership

Monitoring

Analytical skills

English (Advanced)

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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