Hi,
Hope you are doing great,
We have an immediate opportunity for Clinical Standards SME at Chicago, IL.
Below is the job description and if you’d like to pursue this, please
include a word copy of your latest resume along with a daytime phone number
and rate in your response.

*Send resumes to s...@nytpartners.com <s...@nytpartners.com>*

*Role: Clinical Standards SME*
*Location: Chicago, IL*
*Duration: 6 Months *

*Skills:*

   - Reviewing the Study Reports, Report to Study Director for any
   discrepancy related to day of necropsy or any other discrepancy.
   - Mapping of Raw Data (PDF Format) in CDISC SEND standards.
   - Generation of Trial Design Domain (TA,TE,TS,TX).
   - Generation of PC-PP domain, This is completely done Manually.
   - Mapping variables to controlled Terminology.
   - Send Data-set generation.
   - Validation and fixing errors and warnings in SEND domain.
   - Preparing the Study Data Reviewers guide for the study.
   - Generation of Define.XML
   - Placing the complete study package in eDOCS.
   - Submitting the study package to Submission Operations (Regulatory).
   - Finally uploading the package in vDOCS with cover letter to Regulatory.
   - Handling with multiple CRO and evaluating validation on their Study
   package.
   - Reviewing CRO Data.
   - Communication with CRO and Product Vendor.


Thanks and Regards,
Syed Layeeq
New York Technology Partners – Rochester
332 Jefferson Rd.
Rochester, NY 14623
s...@nytpartners.com
www.nytp.com
Yahoo&Gtalk: Syedstaffing

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