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Alimentiv

Posted 9 months ago

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Join our Talent Pool - Clinical Operations Lead (Europe)

WarsawRemoteFull-time

AI Summary

Provides oversight and leadership for clinical monitoring activities in Europe, leading CRAs to ensure protocol, regulatory, and timeline compliance.

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

    Clinical MonitoringFeasibilityICH-GCPPerformance OversightSite ManagementStartupTMFVendor Coordination

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