Sr. Clinical Operations Lead
New
Toronto, Ontario / London, OntarioFull-TimeSenior
Salary78,000 - 130,000 CAD per year
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Job Details
- Experience
- 4-9 years
- Required Skills
- GCPMS Office
Requirements
- College diploma/degree with 7-9 years experience, OR Bachelor's degree with 4-6 years experience.
- Minimum 3 years of CRA experience.
- Strong knowledge of GCP, ICH guidelines, and local clinical research regulations.
- Strong proficiency with EDC systems and MS Office.
- Demonstrated ability in report writing and critical review of research documents.
- Strong interpersonal, organizational, and communication skills.
- Detail-oriented and task-driven approach.
- Health Sciences, Life Sciences, or Nursing specialty preferred.
- SoCRA or ACRP certification preferred.
Responsibilities
- Provide oversight of project deliverables, assigned CRAs, and investigator sites.
- Develop and implement monitoring plans, study tools, and enrollment/recruitment strategies.
- Conduct co-monitoring visits to assess performance and compliance.
- Review visit reports, protocol deviations, and site performance metrics.
- Lead regular CRA calls and provide project-specific training and mentoring.
- Serve as primary liaison between CRAs and the clinical project team.
- Oversee regional startup, feasibility activities, and vendor management.
- Contribute to financial project management including revenue recognition and site payments.
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