Clinical Data Acquisition Manager

4 weeks ago

Copenhagen, Copenhagen, Denmark Genmab Full time

Job Summary

The Senior Manager of Data Management will oversee the acquisition and integration of third-party data to ensure alignment with clinical trials' objectives and regulatory standards.

Key Responsibilities

  • Lead and provide strategic insights into protocol development, focusing on external data collection and integration.
  • Standardize data type specifications to align with Electronic Data Capture (EDC) requirements and clinical trial objectives.
  • Ensure data transfer processes comply with CDASH and SDTM standards, facilitating efficient data analysis and reporting.
  • Develop detailed data transfer specifications for acquiring external data from third-party vendors.
  • Coordinate with vendors to guarantee that data collection is compatible with clinical databases and meets SDTM requirements.
  • Oversee Data Management Contract Research Organizations (DM CROs) for seamless external data transfers.
  • Review and assess vendor contracts, setup specifications, and test data transfers.
  • Proactively identify and resolve issues related to external data transfers throughout the trial lifecycle.

Requirements

  • Bachelor's degree in science or a related field.
  • 3-5+ years of experience in clinical data management with a focus on external data in the biotech/pharma industry.
  • Profound knowledge of oncology trials, EDC systems, and technical aspects of data transfer.
  • Strong understanding of data management processes, tools, methodologies, and documentation.
  • Familiarity with GCPs, SOPs, regulatory requirements, and good data management practices.
  • Proficiency in CDISC (SDTM) standards and clinical data standards development.
  • Proven project management skills.

About Genmab

Genmab is a biotech company dedicated to transforming the lives of patients through innovative cancer treatment. We leverage the effectiveness of an agile working environment to connect employees and innovate.

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