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.
- 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.
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.