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Laboratory Study Manager (Remote)

icon · Sofia

Ново Remote
Remote Senior 🇬🇧 English
ICH-GCP GCLP Human Biological Sample Management

Описание на позицията

About the role

ICON, a global healthcare intelligence and clinical research organisation, is hiring a Laboratory Study Manager (also described as Study Manager Central Labs / Biosampling Project Manager) on a remote basis. The role leads and coordinates central laboratory activities across global clinical studies and acts as the main link between study teams, central laboratory partners and cross-functional stakeholders, ensuring human biological samples are managed throughout the clinical trial lifecycle.

Key responsibilities

  • Serve as the primary point of contact between study teams and central laboratory partners
  • Coordinate management of human biological samples from study start-up through close-out
  • Develop and maintain Human Biological Sample Management Plans and Sample Risk Assessments
  • Ensure sample flow, testing activities and laboratory data delivery processes are set up and maintained
  • Oversee sample chain of custody, laboratory operations and issue resolution across global laboratory networks
  • Manage laboratory budgets, forecasts and performance reporting
  • Collaborate with Clinical Operations, Data Management, Laboratory Vendors, Human Genetics and other teams
  • Act as a subject matter expert and drive continuous improvement of laboratory and sample management processes

Required profile

  • Master's degree in Life Sciences, Medical Sciences or a related discipline
  • Minimum 5 years of experience in clinical laboratory operations and clinical trial conduct
  • Proven track record in project planning, execution and issue resolution
  • Experience managing laboratory vendors and external partners
  • Experience in global, matrixed and multicultural organisations, and leading operational meetings with multiple stakeholders
  • Legal right to work in the country where the role is based

Required skills

  • Strong understanding of central laboratory operations in clinical research
  • Excellent knowledge of ICH-GCP and GCLP requirements
  • Demonstrated project management capability in complex, cross-functional environments
  • Excellent written and verbal communication skills in English

What we offer

  • Competitive base salary and performance-related incentives
  • Health and wellbeing programmes, including medical, dental and vision coverage where applicable
  • Retirement and pension plans, life assurance and disability coverage
  • Employee assistance programmes and learning and development opportunities

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Source : ats:workday

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