Clinical Data Manager / Clinical Data System Administrator Advanced Medtech Solutions

3.0 - 5.0 years

4 - 7 Lacs

vadodara, manjusar

Work from Office

Department - Clinical 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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