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Tuesday, 6 May 2014

Cdisc Conversion Programmer

Cdisc Conversion Programmer
Clinasia Labs Private Limited - Hyderabad, Andhra Pradesh
Data Mapping for SDTM, ADaM. Conversion Programming ---SAS. Data Validation for SDTM and ADaM. Clinical Data Repository Building and Managing. Oncology is Therapeutics Area. Prepared the Data Validation plan (Edit Check Specification). Clinical Trial process, Data Management and applicable regulatory requirements such as US-FDA like21 CFR- Part 11, ICH-GCP, CDISC-SDTM mapping of Clinical data Developing aCRF Annotation as per Metadata
  • guidelines
  • Developing SDTM Mapping Specification
  • Reviewing Open Cdisc Validate and fixing the issues
  • Developing sponsor specific CRF Library in line with CDASH standards
  • Gather and analyze requirements of migration as per SDTM.
  • Conversion of raw data to CDISC-SDTM format.
  • Extracting SAS datasets.
  • Advise team on creating procedures and functions to convert the data into standards
  • Ensuring smooth flow of data to final database for Client.
  • Important point of contact for business mapping and technical issues

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