- Title: Clinical Data Manager
- Code: RCI-9901
- Location: Osseo Minnesota (MN) 55311
- Posted Date: 01/11/2021
- Duration: 6 Months
Talk to our Recruiter
- Name:Sumit Rawat
- Email: email@example.com
- Phone: 908-704-8843 ✖ 232
- Participates in or leads the review of Clinical Research (CR) documents (e.g., protocols, reports and statistical analysis plans) by interacting with various CR groups including: Project Managers, Clinical Scientists and Statisticians.
- Leads data management activities by working with Clinical Scientists, Clinical Research Associates, Clinical Safety Monitors, Systems Analysts, QC Analysts & Standards Librarian.
- May s draft Data Management Plannd Data Review Plans as required.
- Leads the development and defines standard and non-standard edit check specifications by utilizing clinical knowledge to create the parameters surrounding data items.
- Provides significant input to CRF/eCRF design and address technical issues and edit check programming, as well as contributes to the development of data management reports of clinical data.
- Leads Clinical Data Management activities by using Clinical knowledge, data listings and manual review of eCRFs to issue queries and clean data as required.
- Contributes to the monitoring of data quality during study conduct
- Provides information on issues along with proposed solutions
- Ensures data snapshots are ready for analysis by following the guidelines established in the DMP and/or applicable SOPs.
- Ensures database lock/unlock by following the guidelines established in the DMP and/or applicable SOPs.
- Ensures archiving of the study databases and related documents by following the guidelines established in the DMP and/or applicable SOPs.
- Leads the preparation and presentation of data management activities by evaluating and testing new systems and by participating in task force initiatives.
- Bachelor's degree plus 6+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.