Clinical Operations Manager

Job Description

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

This leadership role involves:

• Line managing, coaching, mentoring, and developing Clinical Research Associates across multiple experience levels.
• Managing hiring, onboarding, performance management, and professional development activities.
• Overseeing resource allocation, workload planning, and utilization across clinical trials.
• Collaborating with Project Managers and cross-functional teams to ensure successful study delivery.
• Monitoring staff performance and supporting operational efficiency through established departmental metrics.
• Implementing departmental quality controls and contributing to the development and continuous improvement of quality systems and processes.
• Preparing for and participating in internal audits, sponsor audits, and regulatory inspections.
• Supporting trial execution by resolving operational challenges and facilitating communication between project teams and investigational sites.
• Participating in feasibility assessments for new and ongoing studies.
• Supporting business development activities, including client meetings, networking events, and operational discussions, as needed.

Qualifications

• An MD, PharmD, or a university degree in Life Sciences, or an equivalent combination of education, training, and experience.
• A 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.
• 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.