Job Description

Description BASIC SUMMARY: Perform the execution of Clinical Data Management functions with delegated authority. Interactively participate in the day-to-day development of the client deliverables while providing supervision and mentorship to Data Management Interns. ESSENTIAL DUTIES AND RESPONSIBILITIES: Review study-specific documentation as part of the project team to obtain understanding of study-specific data processing conventions. Prepare data for entry through completion of transmittal verification, data tracking, and completion of manual review processes. Perform data entry in any clinical data management system used by Clinical Data Management. Reconcile project files and other documents generated in data management against a database for accuracy and completeness of data management processes. Investigate and resolve data anomalies. Identify the need for and generate data queries at any point during data processing, based on guidelines set forth in the Data Management Plan (DMP). Issue and review queries for completeness and forward to the project lead or designee. Conduct quality control including case report form to database review processes. Create test data, perform testing procedure of entry screens, and provide test results to the project lead or designee. Work concurrently and accurately on multiple protocols. Execute all coding activities involved with developing and maintaining a clinical trials database for analysis and/or transfer to sponsor. Provide functional oversight of data processing activities including training of staff performing data entry, data cleaning and quality control tasks. Report routine project status and data trends to project lead or departmental management as required. Create case report forms in accordance with the protocol and established standards when necessary. Author portions of or totality of the DMP as required. Serve as resource for project lead and departmental management. Assist in staffing assignments for assigned projects, ensuring that the project is sufficiently staffed with qualified personnel and specific project requirements are met. Provide functional management and supervision of specific projects tasks, as well as conduct timely and through evaluation of work performance of all direct report personnel. Assist in providing in-house instruction and mentorship as part of technical career development for Data Management Interns, including training, progress assessment, and facilitate technical development for direct report employees. Perform all other related duties as assigned. Requirements QUALIFICATIONS: Education: Associate's degree (A.A./A.S.) or equivalent in a scientific, computer, or related discipline. Bachelor's degree preferred. Experience: 1 year related experience in clinical data management. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Certification/Licensure: None. Other: Experience with relational databases and clinical data management systems Demonstrated knowledge of the conduct of general data management and data management quality control activities for a clinical study Ability to read, write, speak and understand English required. PHYSICAL DEMANDS: While performing the duties of this job, the employee is regularly required to talk, hear, type/work at a computer. Specific vision abilities required by this job include close vision and the ability to adjust focus. WORK ENVIRONMENT: General office working conditions, the noise level in the work environment is usually quiet. COMMENTS: Must have a valid driver's license with no limitations on driving availability. #J-18808-Ljbffr

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