Clinical Operations Manager
- Full-time
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
- 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.