Clinical Operations Manager

Company Description

PSI is a leading Contract Research Organization with more than 25 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

We're on the lookout for a knowledgeable, proactive and dedicated person to lead and develop our Clinical Operations team in Canada. In this role, you will establish local operational presence and enjoy all aspects of operational & strategic management.

This is a hybrid role with 3 days based in our Toronto office.

The scope of responsibilities will include:

• Line management of Clinical Operations staff (Clinical Research Associate and Clinical Trial Associates). 
• Management of multiple aspects of clinical research from business development to project execution. 
• Coordination of resource allocation to projects and utilization monitoring.
• Oversight of the staff workload, performance appraisal and career advancement.
• Training, coaching and mentoring the team.
• Hiring, onboarding and integrating new Clinical Operations’ employees.
• Ensuring compliance with GCP standards and internal/external procedures.
• Development and implementation of quality control.
• Regional project oversight.
• Management of the budgets on the country level.
• Maintenance, revision and establishment of processes on the regional level.
• Ensuring smooth operations of the company in Canada, providing full managerial and administrative support to staff in the country, and company management (if applicable).
• Communication point to investigators, regulatory and ethics authorities, clients and vendors for various project-related matters (if applicable).

Qualifications

• College or University degree in Life Sciences preferred. 
• Demonstrated operations experience in a CRO (preferable), or a pharma company.
• At least 3 years’ experience in clinical team management. This includes in-person and remote management. 
• Experience with clinical research sites, R+D processes, legal, regulatory and ethics in Canada. 
• Knowledge of local HR line management processes.
• Basic financial knowledge and demonstrated ability to manage budgets.
• Excellent English communication skills; French speaking skills is a plus.
• Proficiency in standard MS Office applications.
• Strong time management, organizational, leadership, planning and presentation skills, result-oriented approach.