Clinical Operations Manager.

Psi

Buenos Aires

Hybrid

ARS 100,451,000 - 146,813,000

Full time

5 days ago
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Job summary

PSI is seeking an experienced Clinical Operations Manager to lead and grow the LATAM Clinical Operations team. This hybrid role is based in Buenos Aires, offering opportunities to mentor staff, optimize resource use, and ensure high-quality trial delivery across the region.

You will collaborate with Project Managers, support audits, and contribute to continuous improvement of quality systems while advancing trials through regulatory inspections and sponsor interactions.

Qualifications

  • Minimum of 5 years of clinical research experience with people leadership.
  • Onsite CRA experience required.
  • Experience mentoring clinical research professionals in CRO/sponsor environments.
  • Oncology or IBD experience is a plus.
  • Strong communication, organization and problem-solving skills.

Responsibilities

  • Line manage and develop Clinical Operations staff across levels.
  • Oversee hiring, onboarding, performance management, and development.
  • Coordinate resource allocation and workload planning for trials.
  • Collaborate with PMs and cross-functional teams to deliver studies.
  • Support audits and regulatory inspections; implement quality systems.
  • Assist feasibility assessments and sponsor discussions as needed.

Skills

Team leadership
Staff coaching
English proficiency
Regulatory knowledge
Problem solving

Education

MD/PharmD/Life sciences degree

Tools

ICH-GCP knowledge
Clinical trial systems
Microsoft Office

Job description

Job Description

PSI is seeking an experienced and people-focused Clinical Operations Manager to join our team.

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.

This is a hybrid role based in Buenos Aires.

The scope of responsibilities will include:
  • Line manage, coach, mentor, and develop Clinical Operations staff across multiple experience levels.
  • Manage hiring, onboarding, performance management, and professional development activities.
  • Oversee resource allocation, workload planning, and utilization across clinical trials.
  • Collaborate with Project Managers and cross-functional teams to ensure successful study delivery.
  • Monitor staff performance and support operational efficiency through established departmental metrics.
  • Implement departmental quality controls and contribute to the development and continuous improvement of quality systems and processes.
  • Prepare for and participate in internal audits, sponsor audits, and regulatory inspections.
  • Support trial execution by resolving operational challenges and facilitating communication between project teams and investigational sites.
  • Participate in feasibility assessments for new and ongoing studies.
  • Support business development activities, including client meetings, networking events, and operational discussions, as needed.
Qualifications
  • MD, PharmD, or a university degree in Life Sciences
  • Minimum of 5 years of clinical research industry experience, including demonstrated team management or people leadership experience.
  • Previous experience working independently as an onsite Clinical Research Associate (CRA) is required.
  • 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

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

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