Full-Time Clinical Operations Manager (CRA)

The Clinical Operations Manager will be responsible for line management of assigned departmental staff, including 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.

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

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