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Sr. Clinical Operations Lead

2 months, 1 week ago
Canada, United Kingdom
Full-time
Senior
Program Manager
Project and Program Management
Apply Now
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
View All Jobs 32

Description

  • Oversee clinical operations for a project at a regional or global level and ensure delivery of project objectives.
  • Manage and support assigned Clinical Research Associates (CRAs) and investigator sites in line with the monitoring plan, protocol, GCP, ICH guidelines, and local regulations.
  • Serve as the primary liaison between CRAs and the clinical project team, including sponsor and internal stakeholders.
  • Provide project-specific training, mentoring, and operational guidance to regional CRAs.
  • Conduct CRA assessment visits and monitor CRA performance against monitoring responsibilities.
  • Prepare and maintain monitoring plans, training materials, study tools, and other study documentation.
  • Review visit reports, track protocol deviations, and support issue escalation and corrective actions.
  • Implement enrollment and recruitment strategies with the clinical project team.
  • Oversee site and country performance metrics, including recruitment, data collection, and document collection.
  • Support startup, feasibility, vendor management, and other clinical operations deliverables as needed.

Requirements

  • College diploma/degree with 7-9 years of related experience and continuous training, or an undergraduate degree with 4-6 years of experience and substantial ongoing job-related training.
  • A minimum of 3 years of CRA experience.
  • Health Sciences, Life Sciences, or Nursing specialty preferred.
  • SoCRA and/or ACRP certification or designation preferred.
  • Strong experience with EDC systems.
  • Proficiency with MS Office.
  • Strong written and verbal communication skills.
  • Highly effective interpersonal, organizational, and report-writing skills.
  • Strong understanding of GCP, local regulations, IRB/EC requirements, and investigator responsibilities.
  • Ability to manage multiple tasks and meet deadlines in a dynamic environment.

Benefits

  • Home-based remote working arrangement.
  • Base salary of $78,000 to $130,000 per year.
  • Bonus opportunity.
  • Accommodation support available for persons with disabilities during the recruitment process.

Interested in this position?

Apply directly on the company website

Apply Now

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