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 and Experience in EDC Tool development

 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

Perks:
Provident Fund

Work Location: In person

📌 Clinical Data Manager Hyderabad
🏢 Croissance Clinical Research
📍 Hyderabad