Associate/ Centralized Monitoring Lead (Remote)

Novasyte; Buenos Aires; A distancia; ARS 1.500.000 - 6.500.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a dynamic leader for their Centralized Monitoring team. This role involves partnering with project and clinical leads to ensure project objectives are met while optimizing delivery speed, quality, and cost. The successful candidate will oversee clinical deliverables, manage resources, and contribute to developing analytics strategies. The company is committed to pushing the boundaries of human science and data science, making a significant impact in the life sciences industry. If you are passionate about leading teams and driving continuous improvements in clinical operations, this is the opportunity for you.

Formación

• Bachelor's degree in life sciences or related field required.
• Strong written and verbal communication skills, especially in English.

Responsabilidades

• Lead the Centralized Monitoring team and manage project resources.
• Conduct trend analysis of clinical aspects and ensure compliance.

Conocimientos

Leadership

Analytical Skills

Communication Skills

Problem Solving

Organizational Skills

Coaching

Cultural Awareness

Educación

Bachelor's degree in life sciences

Herramientas

RBM specific tools

Descripción del empleo

Novasyte

Job Overview
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:

1. Leadership activities:
   1. 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.
   2. 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.).
   3. May act as Clinical Lead when there is not assigned to the study and at project close out.
   4. Manage project resources (CRAs/ Central Monitors/ Clinical Trial Assistants/ Centralized Monitoring Assistants).
2. Analytical activities:
   1. 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.).
   2. Contribute to developing the study specific analytics strategy and work on developing advanced analytics.
   3. Support project management team to develop monitoring strategy, including monitoring triggers/thresholds.
   4. Attend study team and/or client meetings.
   5. Provide inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections.
   6. 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.
   7. Ensure complete and accurate documentation of all the study specific tools and templates and keep the project Audit ready, including eTMF oversight.
   8. Mentors or coaches for junior staff.

Qualifications:

1. Bachelor's degree in life sciences or related field.
2. Strong written and verbal communication skills including advanced command of English (mandatory).
3. Strong organizational, problem solving and decision making skills.
4. Results and detail-oriented approach to work delivery and output.
5. Excellent motivational, influencing, negotiating and coaching skills.
6. Ability to work on multiple global projects and manage competing priorities.
7. Ability to work across cultures and geographies with a high awareness and understanding of cultural differences.
8. To lead team and effectively work in team.

LI-Remote

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.