Clinical Data Manager: Lead Data Quality & Study Delivery

ICON Strategic Solutions; Warszawa; On-site; PLN 150,000 - 190,000; Full time

Job summary

ICON Strategic Solutions is seeking a Clinical Data Manager to join our client-dedicated team. You will own data management activities from study start-up to close-out, ensuring accurate and inspection-ready data for global projects.

You will collaborate with study teams and vendors, perform EDC review and data cleaning, and contribute to database lock readiness, with a focus on data quality and timely delivery within a fast-paced environment.

Qualifications

• Bachelor's degree in a Life Sciences related discipline.
• 5+ years of Clinical Data Management experience in CRO/pharma/biotech.
• Experience leading studies from start-up through database lock.
• Strong hands-on EDC review, data cleaning, query management, external data reconciliation and UAT.
• Clear communication and ability to work independently within global study teams.
• Veeva EDC experience is desirable but not essential.

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.

Skills

Data management

EDC review

Data cleaning

Query management

Communication

Independence

Veeva EDC

Education

Bachelor's degree in Life Sciences

Tools

Veeva EDC

Job description

ICON Strategic Solutions is seeking a Clinical Data Manager to join our client-dedicated team. You will own data management activities from study start-up to close-out, ensuring accurate and inspection-ready data for global projects.

You will collaborate with study teams and vendors, perform EDC review and data cleaning, and contribute to database lock readiness, with a focus on data quality and timely delivery within a fast-paced environment.