Job Description

PSI is a leading Contract Research Organization with more 30 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

The Clinical Operations Manager will be responsible for the line management of assigned departmental staff to include resource allocation, performance management, and career development.

• 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
• Manages resource workload and utilization
• Manages staff performance to ensure efficiency and productivity
• Mentors 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

• College or University degree in Life Sciences or equivalent experience
• Demonstrated operations experience in a CRO (preferable), or a pharma company
• Bid defense experience is preferable
• At least 5 years of industry experience, as well as at least 2 years’ experience in clinical team management, to include remote team management
• Knowledge of local HR line management processes
• Basic financial knowledge and demonstrated ability to manage budgets
• Proficiency in standard MS Office applications
• Strong time management, organizational, leadership, planning and presentation skills, result-oriented approach

Additional Information

All your information will be kept confidential according to EEO guidelines.

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