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Clinical Data Manager

1 month ago

Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role

Genmab is seeking a highly skilled Clinical Data Manager to join our team in a dynamic biotech environment. As a Clinical Data Manager, you will play a pivotal role in overseeing the acquisition and integration of third-party data, ensuring its alignment with clinical trials' objectives and regulatory standards.

Responsibilities
  • Lead and provide strategic insights into protocol development, specifically focusing on external data collection and integration.
  • Standardize data type specifications to align with Electronic Data Capture (EDC) requirements and clinical trial objectives.
  • Ensure that 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 You
  • Passionate about Genmab's mission and driven to make a significant impact in a dynamic biotech environment.
  • Exceptional technical expertise in clinical data management and external data acquisition.
  • Ability to thrive in a fast-paced setting, maintaining the quality and integrity of clinical data.