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Alimentiv

Posted 6 months ago

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Join our Talent Pool - Clinical Operations Lead (Europe)

WarsawOn-siteFull-time

AI Summary

Clinical Operations Lead role overseeing regional CRAs and monitoring activities, serving as liaison between CRAs, project teams, and sponsors; includes training, site management, and process improvements. Senior COL may lead COLs/CRAs and oversee trial management.

About this role

Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!

We are proactively inviting qualified candidates to join our talent pool for anticipated Clinical Operations Lead needs (COL & Sr. COL) to support our Clinical Monitoring team.

What the process looks like:

  • A Talent Acquisition representative will contact selected candidates to schedule a qualifying call to learn more about your experience, and what your timeline looks like
  • We'll also share details about timelines on our side - note that this Talent Pool is not necessarily for an immediate, active role
  • We'll keep your details on file and in mind - if an active vacancy does arise which matches your seniority and logistical details, we'll reach out to get an interview scheduled with the team

    • 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.

    • Skills

    Budget OversightCo-monitoringData QualityFeasibilityFinancial OversightGCPICH-GCPMentoringMonitoringProject PlanningQuality ReviewRenewal And Regulatory ComplianceReportingSite ManagementSponsor CommunicationStakeholder ManagementStartupStudy DocumentsTMFTrainingVendor Coordination

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