Clinical Data Manager
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Job Description
Clinical Data Manager leading clinical trial data management and data quality for ICON, a global clinical research organisation. Owning study data from start-up through database lock and close-out.
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, including Data Management Plans, Data Review Plans, eCRF Completion Guidelines and Edit Check Specifications
- Conduct EDC and data validation listing UAT and support database lock readiness
- Partner 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
- Work within a collaborative client-dedicated model for a global pharmaceutical partner
Requirements:
- Bachelor's degree in a Life Sciences related discipline
- 5+ years of Clinical Data Management experience within a CRO, pharmaceutical or biotechnology environment
- Experience leading or co-leading studies from start-up through database lock and close-out
- Strong hands-on EDC review, data cleaning, query management, external data reconciliation and UAT experience
- Clear communication skills and the ability to work independently within fast-paced global study teams
- Employment contingent upon having the legal right to work in the country where the role is based
- Veeva EDC experience is desirable but not essential
Benefits:
- 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 wellbeing resources
- Learning and development opportunities through structured training and career pathways
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