Data Manager

Experteer Overview

In this internship, you support clinical data management activities from start‑up to data lock, helping deliver clean study data. You will work within a study team to design CRFs, develop data and validation plans, and ensure quality through UAT and data cleaning processes. You will apply industry standards (ICH, GCP) to daily tasks and contribute to study documentation and data integration efforts. This role offers hands‑on experience in a global, collaborative environment focused on rigorous data management and process improvement.

Retribuzione / Benefits

• Manage project milestones from study start‑up to delivery and monitor task time
• Design the Case Record Form (CRF) and guide CRF approval process
• Develop Data Management Plan and Data Validation Plan with study team input
• For EDC studies, define UAT and execute test activities to ensure eCRF quality
• Respond to eCRF Helpdesk issues in a timely manner
• Prepare CRF completion guidelines and study‑specific data‑entry guidelines
• Perform term coding and raise queries for uncoded terms
• Manage query resolution and data cleaning, including Medical Review listings
• Apply SOPs and industry guidelines (ICH, GCP) and generate study documentation
• Monitor study progress against project plan and elevate issues appropriately
• Run data progress reports, manage queries, and elevate study issues
• Perform timely data integration of CRF and non‑CRF data
• Reconcile external data (SAE, Central Labs, ECGs, etc.)
• Define and execute QC plans and oversee database release/lock
• Plan & prioritize own work and conduct additional activities as required

Responsabilità

• Degree in life science, pharmaceutical, biology or related field or at least 6 months data management experience in pharma
• Basic understanding of ICH and GCP guidelines
• Basic understanding of Data Management processes

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