Responsibilities:

• Lead the creation of the Data Review and Cleaning Plan and development of the data cleaning strategy. Provide oversight of the data validation plan and provide DM insight to maximize the data validation strategy.
• Review CRFs to ensure alignment with protocol; lead and perform sponsor acceptance testing of the eCRF; and ensure database structure meets expectations and provide DM insight to promote effective clinical database structure.
• Define and perform data quality checks and take action to ensure data quality.
• Provide oversight of key DM documentation and ensure inspection readiness; ensure documentation is aligned with best practices and provide improvement recommendations based on DM expertise.
• Drive DM oversight of data releases/DBLs and ensure timely delivery of data deliverables in accordance with Genmab SOPs and ICH/GCP; and ensure data quality for analysis and reporting; prepare for regulatory filings and inspections.
• Drive and support vendor qualification for data management; define/specify scope of work for functional tasks.
• Support process improvement and knowledge management by participating in or leading task forces/ projects.

Requirements:

• Bachelor’s degree in science or a related field.
• Must have 6 years of clinical data management experience in biotech / pharma industry with significant hands-on end-to-end experience in clinical data management practices.
• Experience with clinical trials and the drug development process.
• Significant experience leading data management activities for multiple clinical trials; proficient use of data management systems; advanced knowledge of DM processes, tools, methodologies and documentation; strong understanding of DM strategy.
• Experience and understanding of GCPs, SOPs, regulatory requirements and good data management practices.
• Project management experience.
• Experience within oncology trials is highly preferred.
• Experience with CDISC (SDTM) as well as data collection requirements in oncology trials are highly preferred.

• Lead the creation of the Data Review and Cleaning Plan and development of the data cleaning strategy. Provide oversight of the data validation plan and provide DM insight to maximize the data validation strategy.
• Review CRFs to ensure alignment with protocol; lead and perform sponsor acceptance testing of the eCRF; and ensure database structure meets expectations and provide DM insight to promote effective clinical database structure.
• Define and perform data quality checks and take action to ensure data quality.
• Provide oversight of key DM documentation and ensure inspection readiness; ensure documentation is aligned with best practices and provide improvement recommendations based on DM expertise.
• Drive DM oversight of data releases/DBLs and ensure timely delivery of data deliverables in accordance with Genmab SOPs and ICH/GCP; and ensure data quality for analysis and reporting; prepare for regulatory filings and inspections.
• Drive and support vendor qualification for data management; define/specify scope of work for functional tasks.
• Support process improvement and knowledge management by participating in or leading task forces/ projects