Join our Talent Pool - Clinical Operations Lead (Canada)

23 hours, 47 minutes ago
Full-time
Mid Level
Project and Program Management
Alimentiv

Alimentiv

Alimentiv specializes in providing comprehensive clinical research services for gastrointestinal and liver diseases, leveraging a global site network, advanced medical imaging, and biomarker discovery to enhance patient recruitment and accelerate clini...

Professional Services
251-1K
Founded 1986

Description

  • 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.
  • Manage site, country, and regional performance across startup, recruitment, data quality, TMF, and timeline metrics, escalating risks and issues as needed.
  • Serve as the primary operational liaison between CRAs, project teams, sponsors, and other internal stakeholders.
  • Train, mentor, and support CRAs and COLs on study-specific procedures, expectations, and performance standards.
  • Oversee study startup, feasibility, site management, and, when needed, temporary direct site oversight.
  • Contribute to project planning, financial oversight, monitoring budgets, site payments, pass-through costs, and vendor coordination.
  • Develop and deliver study documents, tools, presentations, and operational updates for sponsors, investigators, and study teams.
  • Support or lead trial management for smaller or limited-scope clinical studies when required.
  • Represent Clinical Operations internally and externally and contribute to process improvement initiatives.

Requirements

  • COL role requires a minimum of 1 year of experience and an Honours Bachelor Degree.
  • Senior COL role requires a minimum of 3 years of experience and an Honours Bachelor Degree.
  • Experience in clinical operations, clinical monitoring, site management, or CRA oversight is required.
  • Knowledge of ICH-GCP, local regulations, and study protocol compliance is required.
  • Experience managing or supporting study startup, feasibility, recruitment, and monitoring deliverables is required.
  • Experience with financial oversight, including monitoring budgets, site payments, or pass-through costs, is preferred.
  • Experience coordinating vendors and supporting country or site selection strategy is preferred.
  • Experience providing leadership, training, mentoring, or performance oversight for CRAs or COLs is preferred.
  • Ability to work remotely and participate in a talent pool for future opportunities is required.
  • Experience supporting process improvement or acting as a subject matter expert is preferred.

Benefits

  • Full-time, permanent remote role.
  • Base salary with eligibility for a performance-based bonus.
  • Health benefits included.
  • Dental benefits included.
  • RRSP matching.
  • Additional benefits package available.
  • Opportunity to join a talent pool for future openings rather than an immediate role.

Interested in this position?

Apply directly on the company website

Apply Now

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