Clinical Data Manager

Croissance Clinical Research

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 SOPs.

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.

Experience : 5 - 8 Years

No. of Openings : 2

Education : B.Pharma, M.Pharma

Role : Clinical Data Manager

Industry Type : Hospitals / Medical / Healthcare Equipments

Gender : [ Male / Female ]

Job Country : India