Clinical Operations Manager

1 month ago


Toronto, Canada PSI CRO Full time
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.




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