Clinical Data Manager
Creative Solutions Services, LLC - Cincinnati, OH

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our client in cincinatti, oh is looking for a Clinical Data Manager II. if interested, please apply to this ad or send your resume and contact details with the job # and job title in the subject line to recruiter@css-llc.net Description: Clinical Data Manager is responsible for the quality and accuracy of the database for a clinical study. Their duties include 1st and 2nd pass entry of Case Report Forms (CRFs) and Data Clarification Forms (DCFs), Quality Control (QC) checks, Data Management Review (DM Review) and creation of study documents. A CDM is assigned multiple studies with direct supervision from management. Responsibility to Direct and supervise aspects of all data management process, ensuring compliance with FDA regulations related to data management. Provide guidance to junior and/or supportive Clinical Database team. Instruct data entry personnel and/or Clinical Research Associates (CRA) in procedures relative to data management. May provide input into Case Report Forms (CRF) design and approve CRFs for production use. Oversee the design Clinical databases, including maintenance of the global library; validate database design; program edit-check procedures and validate new edit-check processes; perform and direct data entry processes; run batch validation and track DCFs through data cleaning; code adverse events and concomitant medications using standard coding dictionaries (MedDRA, WHO Drug); maintain coding dictionaries; lock/freeze databases; extract into SAS datasets for analysis. Administer Oracle Thesaurus Management System repository. Set up new studies in the Clinical Research Management System (CRMS) clinical trial management system, and maintain the CRMS database. Train new CRAs in the use of CRMS. Clinical Data Manager is responsible for the quality and accuracy of the database for a clinical study. Their duties include 1st and 2nd pass entry of Case Report Forms (CRFs) and Data Clarification Forms (DCFs), Quality Control (QC) checks, Data Management Review (DM Review) and creation of study documents. A CDM is assigned multiple studies with direct supervision from management. SKILLS: Excellent written and oral communication skills. Knowledge of Microsoft Office applications. Excellent interpersonal skills, great understanding of team-culture. Demonstrate a nature of proactively, enthusiasm, independent drive, and energetic outlook to tasks. Exceptional organizational skills, Works towards and meets deadlines. Ability to collaborate, build strong partnerships/relationships with all stakeholders. The candidate must be willing to take on additional projects and work overtime. ADDITIONAL KNOWLEDGE: Applicable Standard Operating Procedures. Good Clinical Practices (GxP Regulations; ICH Guidelines; Good Quality Practices). 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidances; Computerized Systems Used In Clinical Trials). Good Clinical Data Management Practices. HIPAA. Drug Development and Approval Process. Clinical Laboratory Testing. Discrepancy Management and Creation of DCFs. EXPERIENCE/EDUCATION: 2-5 years of industry experience in data-management, additional industry experience in the clinical research field is required. A college degree is required, Bachelor’s level is preferred but not required
Creative Solutions Services, LLC - 21 months ago - save job
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There's no mystery behind how Black Box does business. The company distributes and supports voice and data networking infrastructure....