Extensive knowledge of clinical study lifecycle as defined in the clinical SOPs, Good Clinical Practices. Good Understanding of concepts of data management activities (CRF/Edit check development, data management plans, snapshots, data review, data quality). Ability to identify data related issues using study database and data management reports and escalate issues appropriately. Works independently within context of assigned tasks. Responsible for on-time delivery of Data Management deliverables. Experience in testing of clinical databases / edit checks / Study reports and other components.
Desired Skills
• Knowledge of good data management and good clinical practices, Food and Drug Administration 21 CFR Part 11 regulation, and Health Insurance Portability and Accountability Act.
• Experience working in clinical data management applications (e.g. Oracle Clinical) and report tools
• Able to perform routine data management tasks with minimal supervision; receives instruction on new projects
• Ability to use judgment to effectively solve problems
• Effective oral and written communication skills
• Ability to prioritize tasks and manage competing priorities based on project plan expectations
• Team player who effectively works with colleagues
• Experience using Microsoft Office products
• High degree of initiative and self-motivation with a strong sense of accountability
Local candidate to Minneapolis, MN required
Bachelor's Degree required
All your information will be kept confidential according to EEO guidelines.