Associate External Data Specialist
Company Name:-
Covance
Job Location:-
Bengaluru, Karnataka
Job Summary:-
Job Overview:
1.
Ensures electronic vendor data contains all protocol specified parameters, is in correct format, and data populates to the specified fields and patients correctly.
2.
Develop the Data Transfer Agreement and Data Transfer Specifications for vendor data transfers.
3.
Review data discrepancies generated by study specific edit checks for External data and perform the subsequent query management process in resolving the data issues.
4.
Perform validation review of the electronically transmitted data for a sample of total number of patients in the study for loading purposes.
5.
Assist with review of laboratory edit checks, laboratory status reports and laboratory listings.
6.
Work with clinical staff to obtain local laboratory normal ranges for all sites.
Research and resolve discrepant information concerning normal ranges and maintain proper documentation.
7.
Edit and perform QC for local laboratory normal ranges.
Verify that normal ranges are properly attached to patient results in the local lab data collection module.
8.
Communicate to vendors and client problems involving data transfers, data point issues, and validation issues
Education/Qualifications:
Recommended:
Associates or bachelors degree in Medical/Life Science/Computer Science is preferred or equivalent certification in allied health profession from an appropriate accredited institution (E.
g.
Nursing certification, Medical or laboratory technology), or clinical trial industries or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
In Lieu of the above requirement, candidate with two (2) or more years of relevant clinical research experience in Pharmaceutical or CRA Industries may be considered
Experience:
Minimum Required:2 years prior experience in the pharmaceutical, biotechnology, medical device/diagnostics, or clinical trial industries or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
Basic understanding of medical terminology a plus.
Strong organizational, planning, and critical-thinking skills.
Well-polished, inclusive, and engaging communication skills (written and verbal) to support effective inter
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