Data Management Consultant (Pharma)

Company: emagine

  • Location: Copenhagen, Denmark
  • Work mode: Hybrid
  • Employment type: Full-time
  • Posted: Yesterday
  • Offer language: English

Job description

On behalf of a client in the pharmaceutical industry, we are looking for a Data Management Consultant to support non-clinical data management and preparation of SEND-compliant datasets for regulatory submissions.

Main Responsibilities

  • Plan, coordinate and execute data management activities for non-clinical studies
  • Oversee data collection, standardisation and validation
  • Manage metadata and ensure datasets are complete, consistent and compliant
  • Coordinate database release and lock activities
  • Troubleshoot data issues and support timely resolution
  • Work with CRO partners and other stakeholders across studies and projects
  • Prepare and support SEND datasets and documentation for regulatory submissions
  • Provide expert guidance on non-clinical data management and SEND-related topics
  • Ensure data management activities comply with applicable GxP requirements

Key Requirements

  • Solid experience with non-clinical data management
  • Strong hands-on knowledge of Standard for Exchange of Non-clinical Data (SEND)
  • Experience with data standardisation, validation and metadata management
  • Experience preparing datasets for regulatory submissions
  • Experience coordinating data management activities across studies and stakeholders
  • Experience working with CRO partners
  • Knowledge of applicable GxP requirements
  • Relevant life science or data management education: PhD with at least 3–4 years of relevant experience, or MSc with at least 5–7 years of relevant experience, or BSc with 8+ years of relevant experience

Other Details

Assignment duration: 8 months

Location: Måløv (hybrid)

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