Description
Senior Clinical Data ManagerA Biotech company in the Santa Clara area is urgently looking for a Senior Clinical Data Manager to join their team. This is a very urgent position and could be a great opportunity for an experienced individual trying to make a move. Most important requirements for this role is someone who has RAVE experience and has acted as a lead.
Senior Clinical Data Manager Duties:
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. 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.
Please apply to this post as soon as possible if interested and qualified for this position. The hiring manager is trying to set up interviews ASAP as this is a very urgent role.
To find out more about Real please visit www.realstaffing.com