************ PLEASE RESPOND TO [email protected] ****************
****************DIRECT CLIENT *************
********IMMEDIATE NEED ***********
SDTM Functional Analyst (Life sciences Pharma domain)
Rahway, NJ
Long Term**
Rate : $46/hr
*
*
* Responsibility:
* Candidate should have 6-8 yrs of experience in Life sciences pharma domain
* Knowledge of CDISC, SDTM, ODM standards
* Extensive experience in data mappings in SDTM domain and variables, SDTM
based CRF annotation, related processes and standards.
* Understanding of SAS, SAS Drug Discovery systems* .
· Served as a Business Lead to gather requirements for transforming
clinical data as per CDISC SDTM standards for FDA submission.
· Developed detailed SDTM mapping specifications with data
transformation rules for frozen studies and active trials for the EDC Full
Adoption project.
· Provided Pseudo Code's, Mock up's of the SDTM mappings to the
technical team and UAT folks for better understanding of the Mapping Spec.
· Provided business and technical inputs for development of CTDM
(Clinical Trial Data Migration) tool.
· Developed SDTM mapping specification for 10 Zero Defect
Migrations, 23 UAT and Production Verified Studies and 2 conversion studies
· Synchronized Merck specific business rules with CDISC SDTM
standards to design the required mapping standards.
· Created Study Specific Define XML files as per ECHOS and CDISC
standards.
· Performed pre-UAT testing and verification on transformed SDTM
data.
· Performed validation checks on the SDTM domains including
Checking for Required variables etc.
· Provided training on SDTM standards.
· Responsible for importing transformed SDTM data from Oracle
Database to SAS datasets.
· Identify and resolve issues occur during the data flow from
reporting schema to Janus and from Janus to SDTM.
· Knowledge of the CTS, PDAM, Clinical Data Repository (CDR), which
include Janus, Janus Hist, SDTM and Metadata.
· Responsible for creation SDTM Mapping Spec for the CTS data.
· Responsible for creating Intermediate datasets required for
data mapping.
· Responsible for creating SDTM mapping in EPDS application.**
Thanks!!
Vivek Samant
Resource Manager
Optimum Technology Solutions Inc.
*********************************************
Consistently delivering optimum, cost effective, valuable IT-based solutions
to our clients
Optimum Technology Solutions Inc.,
Phone: 615-346-9325
Fax : 615-523-2880
Email: [email protected]
www.optyinc.com
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