Job Description
Functional AreaAllied Health Services, Medical Transcription
IndustryPharma / Biotech
- Develop Case Report Form (CRF), electronic and/or paper.
- Performing Data entry for paper CRF.
- Participate in the review of Clinical research documents (eg. Protocols, Case Report Forms, Reports)
- Participates in EDC database (DB) specification process
- Execution of test scripts and maintaining logs for User Acceptance Testing (UAT)
- Reconcile electronic data transfers from vendor to Sponsor.
- Provide Clinical data management support to Clinical Operations team and Biostatistics Team
- Review and contribute to preparation of protocols, specifically related to the data management section, visit schema and study design.
- Develop Data Management Plan (DMP), maintains DMP throughout Lifecycle of study project and ensure DMP is followed according to study Design and requirements.
- Provides input and reviews clinical trial database design including User Acceptance Testing (UAT).
- Lead EDC database (DB) specification process.
- Reconcile electronic data transfers from vendor to Sponsor.
- Perform training on data management software and practices or trial specific topics as required.
- Identify errors and inconsistencies; resolve them.
- Initiate their resolution either via the field monitor or directly with the investigational site.
- To ensure high quality and timely database locks.
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