Clinical Data Management Director
3 weeks ago
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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