Clinical Data Manager Jobs
Cary, NC
| Description
The primary focus of this position will be to perform a variety of complex and responsible tasks to enter, process, review and validate clinical trial data received in-house and remotely in order to ensure complete, accurate, high quality, regulatory compliant data in support of publications and regulatory submissions. Principal Activities: Develop data entry screens from defined data collection forms and annotate the case report form. Manage and perform user acceptance testing of the data entry system. Define and document edit specifications, and perform user acceptance testing of programmed edits. Define and document data listing specifications, and perform user acceptance testing of programmed data listings. Develop, document, and finalize the data management plan (DMP). Perform pre-, during, and post-data entry review of clinical data, identify data discrepancies and corresponding resolutions, and generate and manage queries. Manage and document data quality checks. Set-up, maintain, and archive electronic and hard-copy project documentation. Perform other activities as required. No Visa Sponsorship Available Requirements. REQUIREMENTS AND ACCOUNTABILITY Requires a Bachelors degree with 2-5 years of clinical data management experience or a Masters degree with 0-2 years of clinical data management experience. The degree must be in a scientific discipline. Experience entering, processing, reviewing and validating clinical data. Possess a thorough knowledge of medical terminology, clinical protocols, data collection documents, and the clinical data review and query process. Proficient on regulatory requirements and SOPs for clinical data . Possess a basic knowledge of SAS. Proficient on Microsoft Word, Excel, and PowerPoint; a standard electronic mail system; and a pharmaceutical industry data management system. Possess effective written and verbal communication skills necessary to interact with personnel at all levels within and external to the company. Demonstrate initiative, sound judgment and flexibility; possess effective time management and organizational skills; and be able to work under deadlines and on multiple projects simultaneously. Experience in solving increasingly difficult problems, taking appropriate corrective action, and recommending improvements. |
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