Clinical Operations Manager

PSI CRO • Remote, UNITED STATES

8d • Remote

About The Position

PSI is seeking an experienced and people-focused Clinical Operations Manager to join their team. This leadership role involves the management, development, and operational oversight of CRA staff. The successful candidate will lead and mentor a high-performing team, ensuring efficient resource utilization, operational excellence, and successful clinical trial delivery. This is a home-based role in the United States, requiring a collaborative leader passionate about people development, quality, and cross-functional partnerships to support study execution.

Requirements

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

Nice To Haves

• Experience supporting audits, inspections, and quality initiatives is preferred.

Responsibilities

• Line manage, coach, mentor, and develop Clinical Research Associates 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level