Lead External Data Quality Manager and Team Leader

3 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time

We are seeking a highly experienced Lead External Data Quality Manager and Team Leader to join our team at Genmab. In this role, you will be responsible for the oversight of External Data Quality Management activities related to effective planning and timely delivery of complete, high-quality, and reliable external data for clinical trials.

As a seasoned leader, you will provide strategic input to support Genmab's clinical development programs to ensure external data management excellence. You will also lead and inspire a team of external data quality managers, emphasizing leadership development within the team.

In collaboration with the Senior Director, Team Lead, External Data Management, you will contribute to and support the strategic direction of External Data Management functional area. This will include driving/supporting audit/inspection readiness activities, process optimizations, and process development within External Data Management in alignment with ICH-GCP and relevant guidelines.

About You
  • You have a Bachelor's degree in science or related area; Master's or Advanced Degree is preferred.
  • You have a 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.
  • You have extensive experience in managing external data quality and vendor oversight, particularly in oncology trials.
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.
Where You Will Work
  • This role offers flexibility with options for remote work in the US (Eastern Time Zone), or a hybrid model in Copenhagen, Denmark, or Utrecht, the Netherlands.

The estimated salary range for this position is between $160,000---$220,000 per year, depending on your skills, qualifications, experience, and location. Certain positions may be eligible for additional forms of compensation, such as bonuses.



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