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Post: CDA II (India)
Job Description
•Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s).
•Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for assigned project(s).
•Generates and enters test data for user acceptance testing.
•Performs role-based User Acceptance Testing (UAT).
•Creates and enters test data for Standard Data Tabulation Model (SDTM) test data.
•Performs SAS mapping QC whereby discrepancies are noted on the SAS mapping test logs.
•Interprets and enters lab normal ranges.
•Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets.
•Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections in cases where queries are not required, per the DVS for the assigned projects. Resolves answered queries correctly and re-queries where appropriate.
Candidate Profile
•Bachelor Degree in the biological sciences or related disciplines in the natural science/health care field.
•Experience with Data Management practices and relational database management software systems preferred.
•Knowledge of clinical data, ICH/Good Clinical Practices and medical terminology.
•Ability to multitask under tight deadlines while providing attention to detail.
Additional Information:
Qualification: Bachelor Degree
Location: Gurgaon
"Industry Type: Pharma/ Biotech/Clinical Research
Requisition #: 16006016
End Date: 25th Feb., 2017
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