Description
This position is NonExempt. Hours over 40 will be paid at Time and a Half.*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 draft Data Management Plans and 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
*Hands on experience in writing specificaitons for reports (EDC, non EDC systems)
*EDC experience is a must
*Medidata RAVE and Oracle InForm experience is required to perform the tasks effectively
To find out more about Real please visit www.realstaffing.com