Description
Abbot Vascular Inc. -Santa Clara, CaliforniaSr. Clinical Data Manager
Duration: 2 Years
Rate: $55+ (Hourly)
Key Responsibilities:
-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.
Qualifications:
-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.
-Medidata Rave experience is a must.