Clinical Data Management Director

2 weeks ago

Copenhagen, Copenhagen, Denmark Genmab Full time

The Role

As a (Senior) Manager in External Data Acquisition, you will play a pivotal role within our Clinical Data Management team at Genmab. Your primary responsibility will be to oversee 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, 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.
      • Collaborate with internal teams (Biomarker Operations, Data Management, Data Analytics, Medical, Statistics, etc.) and external partners to ensure adherence to Genmab's requirements and timelines.

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.

Where you will work

  • This role is remote in the US. The US candidates must live in the Eastern Time Zone.
  • Copenhagen, DK, or Utrecht, the Netherlands, and can be hybrid (3 days in the office/2 remote).

At Genmab, we prioritize employee work-life balance and offer an agile working environment. Our community-based spaces are designed to connect employees and foster innovation.

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