Clinical Operations Lead

Company Description

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

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

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.