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Clinical Data Manager
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Clinical Data Manager
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Clinical Data Manager Lead
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Director, Team Lead, External Data Quality Management, Clinical Data Management
2 months ago
The Director, Team Lead, External Data Quality Management, Clinical Data Management at Genmab is operationally 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.
The Director will provide oversight to ensure end-to-end external data reconciliation/management activities are consistent across the portfolio. The employee will also provide strategic input to support Genmab clinical development programs to ensure external data management excellence.
In the role of Team Lead, the employee will be responsible for managing, developing, supervising, and supporting the employees in External Data Management and ensuring that the employees' competencies reflect their responsibilities, as outlined in their job descriptions. The Team Lead will be part of the External Data Management Leadership Team which defines the overall strategy and areas for development of External Data Management.
In collaboration with the Senior Director, Team Lead, External Data Management, contributes to and supports the strategic direction of External Data Management functional area and ensures activities and processes support the efficient and effective execution of clinical trials, development of standards, support system oversight activities as well as drive/support audit/inspection readiness activities. Furthermore, it is expected that the employee will lead/support and facilitate process optimizations and process development within External Data Management in alignment with ICH-GCP and relevant guidelines.
Key Responsibilities- Lead and inspire a team of external data quality managers, emphasizing leadership development within the team.
- 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
- Contributes to the overall strategy, unified objectives, and areas for development of
- Foster a culture of continuous improvement and professional growth within the External Data Management team.
- Provide mentorship and career development opportunities for all team members, focusing on building leadership skills.
- Spearhead initiatives that promote integration and strategic alignment across various departments.
- Arranges lessons learned to share learnings
- Proactively contributes to the support a global organization
- 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.
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
