Lead Typescript Engineer - Remote & Growth

Agileengine, Llc.; Mar del Plata; Remote; ARS 168,162,000 - 244,600,000; Full time

Job summary

Agileengine is seeking a Centralized Monitoring Lead for LATAM with remote work across multiple locations in the region. You will partner with project and clinical leads to ensure delivery aligns with contract, while optimizing speed, quality and cost in accordance with SOPs.

The role emphasizes leadership of the monitoring team, risk identification, and mentoring of junior staff across global projects. English fluency is mandatory and strong communication is required.

Qualifications

• Bachelor's degree in life sciences or related field.
• +3 years of clinical monitoring experience (remote or on-site).
• +2 years in a Lead role.
• Advanced knowledge of ICH GCP and local regulations.
• Strong English communication (mandatory).
• Excellent organizational, problem solving and decision making skills.
• Motivational, influencing, negotiating and coaching abilities.

Responsibilities

• Lead the Centralized Monitoring team and oversee clinical deliverables per protocol and SOPs.
• Act as Unblinded Clinical Lead and manage IPs and regulatory tasks.
• Support project management with monitoring strategy and triggers.
• Attend study team and client meetings and provide input to key decision makers.
• Mentor junior staff and ensure audit readiness of tools and templates.

Skills

Leadership

Analytical thinking

Communication

Mentoring

Education

Bachelor's degree in life sciences

Job description

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.

EEO Minorities/Females/Protected Veterans/Disabled