Original listing text, shown exactly as published by the company.
About the Role(s)
- Clinical Operations Lead
- Provide overall oversight of regional CRAs to ensure site compliance with study protocols, ICH-GCP, local regulations, and project timelines.
- Lead and support monitoring activities, including co-monitoring visits and quality review of monitoring reports.
- Actively manage site, country, and regional performance (startup, recruitment, data quality, TMF, and timelines), escalating risks and issues as needed.
- Serve as the primary operational liaison between CRAs, project teams, and sponsors, delivering regular status updates and guidance.
- Train, mentor, and support CRAs on study-specific procedures, expectations, and performance standards.
- Oversee study startup, feasibility, and site management activities, including temporary direct site oversight when required.
- Contribute to project planning, financial oversight, and vendor coordination as applicable.
- Develop and deliver key study documents, tools, and presentations for sponsors, investigators, and study teams.
- Senior Clinical Operations Lead
- Provide strategic oversight of Clinical Operations Leads (COLs) and regional CRAs to ensure compliance with study protocols, ICH-GCP, local regulations, and timelines.
- Lead study-level monitoring and site management deliverables, including visit quality, recruitment, essential documents, and adherence to monitoring plans.
- Oversee country and site startup, feasibility, and vendor management activities, contributing to country/site selection strategy.
- Serve as the primary monitoring and site management liaison with sponsors, project teams, and internal stakeholders.
- Provide leadership, training, mentoring, and performance oversight for COLs and CRAs, including CRA assessments.
- Ensure high-quality, timely study execution, including financial oversight related to monitoring budgets, site payments, and pass-through costs.
- Contribute to or lead overall trial management for smaller or limited-scope clinical studies when required.
- Act as a subject matter expert, supporting process improvement initiatives, mentoring COLs, and representing Clinical Operations internally and externally.
Qualifications (may vary depending on role needs)
- COL - minimum 1 year experience + Honours Bachelor Degree
- Sr. COL - Minimum 3 years experience + Honours Bachelor Degree
Compensation/Total Rewards
- Compensation may vary depending on the role seniority, geographic location, and candidate experience.
- All full-time, permanent roles will include a base salary + eligibility for performance-based bonus, as well as a variety of benefits such as health, dental, and more!
- If contacted for an initial call, a member of our TA team will be happy to share more.
