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Join our Talent Pool - Clinical Operations Lead (Europe)

23 hours, 22 minutes ago
Poland
Full-time
Junior
Operations 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 4

Description

  • Provide oversight of regional CRAs to ensure 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 timelines, escalating risks and issues as needed.
  • Serve as the primary operational liaison between CRAs, project teams, sponsors, and internal stakeholders.
  • Train, mentor, and support CRAs and COLs on study procedures, expectations, and performance standards.
  • Oversee study startup, feasibility, site management, and vendor coordination activities.
  • Contribute to project planning, financial oversight, and monitoring budget-related activities.
  • Develop and deliver study documents, tools, presentations, and status updates for sponsors and study teams.
  • Oversee study-level monitoring and site management deliverables, including visit quality, recruitment, essential documents, and adherence to monitoring plans.
  • Support trial management for smaller or limited-scope clinical studies when required.

Requirements

  • Honours Bachelor Degree.
  • Minimum 1 year of experience for Clinical Operations Lead (COL) role.
  • Minimum 3 years of experience for Senior Clinical Operations Lead (Sr. COL) role.
  • Experience supporting clinical monitoring and site management activities.
  • Knowledge of study protocols, ICH-GCP, and local regulations.
  • Experience with CRA leadership, training, mentoring, or performance oversight.
  • Experience contributing to feasibility, startup, vendor management, or country/site selection activities (preferred for Sr. COL).
  • Experience with financial oversight, monitoring budgets, site payments, or pass-through costs.
  • Ability to support or lead process improvement initiatives and represent Clinical Operations internally and externally (preferred for Sr. COL).

Benefits

  • Full-time, permanent role.
  • Remote work arrangement.
  • Base salary.
  • Eligibility for performance-based bonus.
  • Health benefits.
  • Dental benefits.
  • Additional benefits package included.

Interested in this position?

Apply directly on the company website

Apply Now

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