Clinical Operations Manager

Company Description

PSI is a leading Contract Research Organization with more than 29 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

This is a home-based role for candidates based on the West Coast (Pacific Time Zone) in the United States.

• Line manages assigned departmental staff (Clinical Research Associates)
• Interacts with other PSI departments on issues resolution and joint initiatives
• Conducts performance appraisal and fosters professional development of departmental staff
• Administratively supervises departmental staff
• Manages resource allocation to projects and resolution of resourcing conflicts, resource workload and utilization, as well as staff performance to ensure efficiency and productivity
• Provides mentorship to department staff
• Plans training and tracks its completion for the assigned department staff
• Develops and implements quality systems, including quality systems documents (shared responsibility with Senior Clinical Operations Manager and Associate Director Clinical Operations)
• Implements quality controls within the department
• Prepares for and participates in site and systems audits/ regulatory inspections 
• Performs supervised monitoring visits (shared responsibility with Associate Director Clinical Operations)
• Oversees planning, conduct and reporting of field training (shared responsibility with Associate Director Clinical Operations)
• Participates in Risk Review Meetings and CAPA investigation meetings
• Manages crisis and resolves conflicts on project and trial site levels
• Attends project review meetings with the local project teams
• Participates in project-specific site identification and selection
• Ensures enrollment in ongoing projects and communication with sites
• Participates in feasibility assessment of potential and ongoing projects
• Assists with Business Development tasks such as client meetings, trade fairs, key medical events and networking with medical communities and opinion leaders

Qualifications

• MD, PharmD or university degree in Life Sciences
• At least 5 years’ industry experience in clinical research with verified relevant experience in line management
• Previous line manager experience 
• Previous experience as a Clinical Research Associate/Monitor
• Candidates based in Pacific Time Zone strongly preferred

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.