Clinical Data Management

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 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.

• Experience

  1 - 2 Years

• No. of Openings

  3

• Education

  B.Pharma, M.Pharma

• Role

  Clinical Data Management

• Industry Type

  Call Centre / BPO / KPO / ITES / LPO

• Gender

  [ Male / Female ]

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Office