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Clinical Data Manager

icon · Warsaw

New
Senior 🇬🇧 English
EDC Veeva EDC UAT eCRF Data Management Plan eTMF

Job description

About the role

ICON, a global healthcare intelligence and clinical research organisation, is hiring a Clinical Data Manager in Warsaw within its Strategic Solutions business. The role is client-dedicated to one of ICON's global pharmaceutical partners, supporting the delivery of accurate, reliable and inspection-ready clinical data from study start-up through database lock and close-out.

Key responsibilities

  • Lead or co-lead data management activities across assigned studies from start-up through close-out.
  • Perform EDC data review, data cleaning, query management and reconciliation of external data sources.
  • Create and maintain study documentation such as Data Management Plans, Data Review Plans, eCRF completion guidelines and edit check specifications.
  • Run EDC and data validation listing UAT and support database lock readiness.
  • Work with study teams and vendors to resolve data issues, including eCOA, PK, biomarker, local laboratory and safety data discrepancies.
  • Support SAE and protocol deviation reconciliation, issue log maintenance, metrics reporting and eTMF filing.

Required profile

  • Bachelor's degree in a life sciences-related discipline.
  • 5+ years of clinical data management experience in a CRO, pharmaceutical or biotechnology environment.
  • Experience leading or co-leading studies from start-up through database lock and close-out.
  • Clear communication skills and the ability to work independently in fast-paced global study teams.
  • Legal right to work in the country where the role is based.

Required skills

  • Hands-on EDC review, data cleaning, query management, external data reconciliation and UAT.
  • Veeva EDC experience is desirable but not essential.

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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Published 11 hours ago

Expires 1 month from now

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Warsaw