Remote Senior Golang Developer — Growth, Impact & Flex Days

Proxify; La Pampa; Teletrabalho; ARS 136 687 000 - 197 436 000; Tempo integral

Resumo da oferta

Kelly is seeking a Centralized Monitoring Lead (Remote) for LATAM to partner with project and clinical leads, delivering project objectives with optimized speed, quality and cost while adhering to IQVIA SOPs and guidelines. This role requires leadership across global projects and advanced English communication.

The ideal candidate has a life sciences background, 3 years in clinical monitoring, 2 years in a lead role, and strong analytical and coaching skills to mentor juniors in a remote,

Qualificações

• Bachelor's degree in life sciences or related field.
• 3 years of relevant clinical monitoring experience (remote or on site CRA). Advanced knowledge of clinical trial conduct and regulatory requirements (ICH GCP, local laws).
• 2 years in a Lead role.

Responsabilidades

• Oversee clinical deliverables on global projects per protocol and SOPs.
• Unblinded Clinical Lead; IP management; risk identification and mitigation.
• May act as Clinical Lead when not assigned to the study or at project closeout.
• Manage project resources (CRAs, Central Monitors, CTAs, Centralized Monitoring Assistants).
• Monitor study/site metrics; trend analysis and action planning; RBM tools usage.

Conhecimentos

English proficiency

Leadership

Team leadership

Attention to detail

Multitasking

Coaching/Influencing

Organizational skills

Formação académica

Bachelors in life sciences

Descrição da oferta de emprego

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.

#LI-NRJ #LI-Remote

EEO Minorities/Females/Protected Veterans/Disabled

Recruiter Role at Kelly

**Together, we change lives.**
Kelly is a team of experts driven by our belief that the impact of the right person in the right job is limitless.
No matter where you are in your career journey, you can apply your knowledge and passion to move people, organizations, and communities forward. You'll have opportunities to grow your expertise and capabilities, both professionally and personally. As a team, we celebrate inclusion, caring, and collaboration. As a company, we value your contributions, work