Clinical Data ManagerPosted: November 5, 2009
Clinical Data Manager Job ID: HITS11091000 Clinical Data Manager - Bethesda, MD - HITS11091000 Description: Clinical Data Manager Job Id: HITS11091000 Job Description: •Manage the delivery of high quality data from project start-up and planning to project execution and project closeout on several projects •Independently perform project specific quality control and quality assurance tasks on all projects responsible for as well as when requested by HOIS management •Ensure consistency, accuracy, and adherence to federal regulations, Good Clinical Practice, Good Clinical Data Management Practices, as well as SOPs and Working Instructions •Manage patient protocol information and review protocol and incorporate protocol-specific guidelines into the review of clinical trial data on several projects simultaneously •Contribute to the design of the databases and forms, ensuring they meet requirements for the entry and reporting of clinical data of varying complexity •Test new processes and systems for the management of data in clinical trials •Test clinical trial databases and data entry screens assuring compliance with protocol and institutional processes and procedures •Process, track, and validate data accurately and on time, in accordance with data processing and entry instructions •Perform data abstraction and data entry on several different protocols into multiple clinical databases or pharmaceutical/CTMS paper CRFs •Develop and extract patient clinical data reports for publications and presentations •Possess proficiency with clinical databases and report tools •Identify project specific reports and assist in the development of these reports •Prepare, review, and submit clinical data to monitoring agencies. •Maintain client communication regarding data management project status and review key project questions with client •Communicate project status and key project issues to management •Perform other duties as directed by CDM Supervisor, and research team Qualifications: •Minimum: BS/BA in health-related field, and 3-4 years relevant experience. Extensive experience (5+ years) can be substituted for education. •Experience and demonstrated proficiency in all types of clinical data management (data abstraction, query resolution, data reporting and analysis). Preferred Additional Skills: •Health or clinical certification (e.g., CCRP) highly desirable. •Prior supervisory experience a plus. • Excellent organizational, communication and computer skills By submitting your résumé for this position, you understand and agree that Harris Corporation may share your résumé, as well as any other related personal information or documentation you provide, with its subsidiaries and affiliated companies for the purpose of considering you for other available positions. Requirements: Expertise Technical Education BS/BA JobType Full Time Locale USA - MD - Bethesda Preferred Language English
Please refer to job code harris-178463 when responding to this ad.
| Category: | Biotech/Pharmaceutical |
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> Clinical Data Management
| | Location: | Bethesda, MD | | County: | Montgomery County | | ZIP Code: | 20810 | | Pay Rate: | Open | | Job Terms: | full time | | Company: | Harris Corporation | | Phone: | email only please | | Fax: | email only please |
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