Clinical Operations Lead.

Psi

Buenos Aires

On-site

ARS 900,000 - 1,300,000

Full time

6 days ago
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Job summary

Psi is seeking a knowledgeable Clinical Operations leader to drive the LATAM region. You will manage a high-performing team, oversee monitoring visits, and ensure efficient use of resources and compliance with ICH-GCP guidelines.

The role emphasizes mentorship, staff development, and strategic contributions to clinical trial delivery across multiple sites. Strong English communication and leadership are essential.

Qualifications

  • MD, PharmD, or a university degree in Life Sciences.
  • Minimum 4 years of onsite Clinical Research Associate experience.
  • Experience mentoring clinical research professionals in CRO or sponsor settings.
  • Oncology or IBD experience a plus.
  • Strong leadership and employee development skills.
  • Knowledge of ICH-GCP and regulatory requirements.

Responsibilities

  • Line manage, coach, mentor, and develop Clinical Operations staff across multiple experience levels.
  • Supervises and conducts training of Monitors.
  • Mentors Monitors.
  • Plans and conducts supervised monitoring visits with training, authorization, and ongoing assessment purposes.
  • Supports professional development of Monitors.
  • Contributes to the performance appraisal of Monitors.
  • Supports Clinical Operations Managers with resource allocation and utilization of departmental staff.
  • Performs other Clinical Operations supervisory tasks.

Skills

Leadership
Coaching
Employee development
Resource planning
Workload management
Performance management
ICH-GCP knowledge
Regulatory compliance
Stakeholder management
Communication

Education

MD, PharmD, or Life Sciences degree

Tools

Microsoft Office
Clinical research systems

Job description

Job Description

We’re looking for a knowledgeable, proactive, and result-oriented professional to join our management team and help lead and further develop our Clinical Operations team in Latin America region. You will lead and mentor a high-performing team while ensuring efficient resource utilization, operational excellence, and the successful delivery of clinical trials. In this role, you will enjoy a broad range of operational and strategic management responsibilities, while contributing to the continued growth and success of the region.

The scope of responsibilities will include:
  • Line manage, coach, mentor, and develop Clinical Operations staff across multiple experience levels.
  • Supervises and conducts training of Monitors.
  • Mentors Monitors.
  • Plans and conducts supervised monitoring visits with training, authorization, and ongoing assessment purposes.
  • Supports professional development of Monitors.
  • Contributes to the performance appraisal of Monitors.
  • Supports Clinical Operations Managers with resource allocation and utilization of departmental staff.
  • Performs other Clinical Operations supervisory tasks.
Qualifications
  • MD, PharmD, or a university degree in Life Sciences
  • Previous clinical research industry experience is required.
  • Previous experience working independently as an onsite Clinical Research Associate (CRA) is required (minimum of 4 years)
  • Previous experience managing or mentoring clinical research professionals in a CRO, sponsor, or related clinical research environment.
  • Previous experience with Oncology or IBD is a plus.
  • Strong leadership, coaching, and employee development skills.
  • Experience with resource planning, workload management, and performance management.
  • Working knowledge of ICH-GCP, applicable regulatory requirements, and clinical trial operations.
  • Experience supporting audits, inspections, and quality initiatives is preferred.
  • Excellent communication, organizational, and problem-solving skills.
  • Proficiency with Microsoft Office applications and clinical research systems.
  • Advanced English proficiency (written and spoken).
  • Strong interpersonal skills with the ability to build trust, foster collaboration, and develop high-performing teams.
Additional Information

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