Clinical Data Management Director

3 weeks ago


Copenhagen, Copenhagen, Denmark Genmab Full time

The Director of Clinical Data Management at Genmab is responsible for overseeing the External Data Quality Management function, ensuring the timely delivery of high-quality external data for clinical trials.

The Director will provide strategic input to support Genmab clinical development programs, ensuring external data management excellence. They will also lead and inspire a team of external data quality managers, emphasizing leadership development within the team.

Key Responsibilities

  • Define and execute the strategic vision for the External Data Quality Management function, aligning with broader corporate goals.
  • Champion the support and development of external data management activities to enhance trial efficiency.
  • Lead external data vendor collaborations to optimize quality and performance.
  • Ensure end-to-end data management consistency within External Data Management.

Requirements

  • Bachelor's degree in science or related area; Master's or Advanced Degree preferred.
  • Minimum of 12 years of clinical data management experience in the biotech/pharmaceutical industry; significant end-to-end, hands-on experience in all aspects of data management or equivalent.
  • Extensive experience in managing external data quality and vendor oversight, particularly in oncology trials.
  • Expertise in data management systems, processes, tools, and regulatory requirements.
  • Significant experience in working with clinical trials and the drug development process.
  • Significant experience of GCPs, SOPs, regulatory requirements, and good data management practices.
  • Proven ability to manage and mentor a team, with strong leadership skills.
  • Excellent communication and project management skills.

About Genmab

Genmab is a biotechnology company that leverages the effectiveness of an agile working environment to connect employees and innovate. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories.



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