Project Management
Clinical development/trial conduct, including ICH-GCP
Document creation and management
Process development
Analytical and ability to interpret and present clinical data
IT skills
Bachelor's degree in science or related area (or equivalent)
10+ years of experience in clinical data management experience in biotech/
pharma industry; significant hands-on experience in all aspects of data
management.
Experience within all phases of clinical trials.
Experience with clinical trials and the drug development process
Significant experience leading data management activities in clinical trials;
advanced use of data management systems; advanced knowledge of DM processes,
tools, methodologies and documentation; advanced understanding of DM strategy
Experience with CDISC (SDTM); as well as data collection requirements in
clinical trials
Experience and understanding of the complex and interdependent relationships
between protocol development, data collection, data review and cleaning
activities and analysis and reporting in clinical trials
Experience and understanding of GCPs, SOPs, regulatory requirements and good
data management practices
Experience working on early and late-stage submissions as per local/regulatory
requirements
Experience working in and leading cross-functional teams
