Hiring For Clinical Data Manager

Key Skills

Clinical Research Clinical Data Management Medidata Rave

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.
  • Experience

    5 - 8 Years

  • No. of Openings

    2

  • Role

    Clinical Data Manager

  • Industry Type

    Hospitals / Medical / Healthcare Equipments

  • Gender

    [ Male / Female ]

  • Job Country

    India

  • Type of Job

    Full Time

  • Work Location Type

    Work from Office

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