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.

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