Overview
Skills
Job Details
Job Title: Clinical Operations Lead
Location: Mississauga, ON, CA Hybrid (3 Days Onsite)
Type: Long-term Contract
Work Authorization: Open to candidates eligible to work in Canada
Industry: Pharmaceuticals / Clinical Research
Job Summary:
We are seeking a highly skilled Clinical Operations Lead to oversee cross-functional study teams and ensure the delivery of clinical trials across all phases (Phase 1b IV). The ideal candidate will bring strong clinical operations experience, leadership skills, and a deep understanding of ICH/Google Cloud Platform regulations.
Key Responsibilities:
Lead global Study Management Teams (SMTs) for clinical trials
Drive study timelines, budgets, vendor oversight, and operational strategy
Manage CROs, vendors, and third-party labs (e.g., IxRS, Central Labs)
Oversee protocol amendments, feasibility assessments, and patient recruitment strategies
Ensure Google Cloud Platform compliance, audit readiness, and timely documentation
Partner cross-functionally with regulatory, IT, data management, and supply chain teams
Support responses to Health Authorities and manage corrective action plans
Qualifications:
University degree in life sciences or related field
Strong understanding of ICH-Google Cloud Platform and regulatory compliance
5+ years of experience in clinical operations (global study experience preferred)
Experience leading vendor/CRO management and budget tracking
Proven ability to lead study teams and collaborate in a cross-functional environment
Excellent communication and problem-solving skills
Proficient with MS Office and clinical systems
Additional Info:
Hybrid work required onsite presence 3 days per week in Mississauga
Must be able to work in Canada
Strong attention to detail and ability to manage multiple timelines