Clinical Data Manager Job in Bethesda, Maryland US
Clinical Data Manager
Job ID: HITS03121019 Clinical Data Manager - Bethesda, MD - HITS03121019 Description: Job Title: Clinical Data Manager Job ID: HITS03121019 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 HITS 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 clients ? Develop and maintain good communications and working relationships within HITS CDM staff and government research team. ? Communicate project status and key project issues to management ? Perform other duties as directed by CDM Supervisor, and research team Qualifications: ? Bachelor's degree in the clinical/health related field plus 3 years experience (or the equivalent). ? Understanding of clinical research and medical terminology and ability to abstract data from source documents. ? Data entry and database experience. Preferred Additional Skills: ? Clinical data management or health-related certification (e.g., CCRP) a plus. ? Excellent organizational, communication, and computer skills required. Please be aware that many of our positions require a security clearance, or the ability to obtain one. Security clearances may only be granted to U.S. citizens. In addition, applicants who accept a conditional offer of employment may be subject to government security investigation(s) and must meet eligibility requirements for access to classified information. By submitting your r sum for this position, you understand and agree that Harris Corporation may share your r sum, 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 High School (or equivalent work experience) JobType Full Time Locale USA - MD - Bethesda Preferred Language English