Clinical Data Manager / Clinical Data System Administrator

3 - 5 years

4 - 7 Lacs

Posted:None| Platform: Naukri logo

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Job Type

Full Time

Job Description

Department -

Roles and Responsibilities:

  • End to End clinical data management and pertinent documentation for clinical studies and real-world data collection.

  • Managing vendors for CDM

  • Conducting User Acceptance Testing

  • Provide guidance on training requirements in relation data management

  • System and technical Skills

  • Regulations and Standards

    21CFR part 11, GDPR, ISO 27001, SDLC and ISO 62304, CDISC standards

Databases & ORM:

  • EDC databases - Clinion, OCRDC, Oracle one, Inform, Open clinica, etc.

  • MS Access

Tools:

MS office, Power Automate, Power BI, MedDRA, WHODD, Rave, Clinion, Research Manager

  • Understanding of the Medical Device industry

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