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Clinical Data Manager


Source:
TIMESJOBS.COM
Location:
Secunderabad, Telangana
Date:
08-11-2016
Job Code:
58231540
Categories:
  • Biotechnology & Science
Applying for this job will take you to an external site
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Job Details

Provide Clinical data management support to Clinical Operations team and/or study project, Clinical Data Management team and Biostatistics team. Participates in the review of Clinical research documents (eg. Protocols, Case Report Forms, Reports and Statistical analysis).Job DescriptionDevelops Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements.Develop Case Report Form (CRF), electronic and/or paper.Develop database (DB) clinical trial data specifications, including CRF design, user requirements, edit rules/checks, query logic and data validations.Lead EDC database (DB) specification processDevelops Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.Reconcile electronic data transfers from vendor to Sponsor.Develop test scripts and execution logs for User Acceptance Testing (UATCoordination of UAT of CRF build and validation documents, included but not limited to edit check document, issue logs, UAT summary report.Maintenance/tracking of EDC user management and other Clinical databases across allocated Clinical trials, including but not limited to, compiling master user lists and activating/deactivating user accounts.Perform training on study trial for EDC and create user guides.
Additional Degree: B.Pharm. (Pharmacy)

Experience: 3-4

Requirements

Bio-Technology Research | Data Management/ Statistics | Documentation/ Medical Writing
Applying for this job will take you to an external site

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