Clinical Data Manager

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), 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 Job Types: Full-time, Permanent Benefits: Provident Fund Schedule: Day shift Work Location: In person Application Deadline: 22/06/2025