Croissance Clinical Research Pvt Ltd jobs - Clinical Data Manager

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),and 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, and 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.