No of openings : 01
Job Code: CCROO8D
Experience: 3 to 4 yrs in Clinical Data Management.
Job Description :
· Organizing Kick-off meetings with the client co-ordination with the functional Head.
· Responsible for allocating the project/Study to team members.
· Responsible for Review and Internal approval of Data Management Plan (DMP),Case Report Form (CRF), Edit check Specification Document (ESD).
· Responsible for Review and Internal approval of Data Entry Guidelines, Self-Evident Correction Document (SEC).
· Internal approval of Annotated CRF (aCRF) and Functional Design Specification (FDS) Document.
· Responsible for preparing and training the SOP’s.
· Responsible for approval of database screens, Edit checks designed in database and DCF/Query tracker.
· Internal Quality Control for all Data Management Documents like Data Management Plan, Annotated CRF, Functional Design Specification Document, Edit check Specification Document.
· Responsible for Issuing the Database Test Certificate.
· Responsible for Database Lock and Unlock procedures.
· Responsible for exporting the data to SAS team for analysis.
· Responsible for Review and approval of Master Data Management File(MDMF).
· Responsible for Data Management Presentation in Investigator meeting.
· Providing inputs for proposal development in co-ordination with the Function Head.
· Responsible for Communication with the client pertaining to the study/Project assigned.