Clinical Data Manager - Katalyst Healthcares & Life Sciences
Princeton, NJ 08540
About the Job
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.
- Bachelor's degree in science or related area.
- Must have 8 or more 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 highly preferred.
- Experience with CDISC (SDTM) as well as data collection requirements in oncology trials highly preferred.
Source : Katalyst Healthcares & Life Sciences
