Clinical Data Manager
icon · Warsaw
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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