Clinical Operations Manager

About the role

PSI, a Contract Research Organization with more than 30 years of experience, is looking for an experienced, people-focused Clinical Operations Manager to join its management team and lead and develop the Clinical Operations team in the Latin America region. The role is hybrid and based in Buenos Aires.

Key responsibilities

• Line manage, coach, mentor and develop Clinical Operations staff across multiple experience levels
• Manage hiring, onboarding, performance management and professional development
• 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 using departmental metrics and implement quality controls and continuous improvement of quality systems
• Prepare for and take part in internal audits, sponsor audits and regulatory inspections
• Resolve operational challenges and support communication between project teams and investigational sites
• Take part in feasibility assessments for new and ongoing studies and support business development activities such as client meetings and networking events

Required profile

• MD, PharmD or a university degree in Life Sciences
• At least 5 years of clinical research experience, including team management or people leadership
• Previous independent work as an onsite Clinical Research Associate (CRA)
• Experience managing or mentoring clinical research professionals in a CRO, sponsor or related environment
• Experience with Oncology or IBD is a plus
• Advanced written and spoken English

Required skills

• Working knowledge of ICH-GCP, applicable regulations and clinical trial operations
• Resource planning, workload management and performance management
• Microsoft Office and clinical research systems
• Audits, inspections and quality initiatives (preferred)