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This position will oversee the activities of the Clinical Data Management staff, including the development of validated data management systems with SOPs, workflows, and electronic clinical data systems. · Implement data management system for specific projects. · Train Clinical Data Management Team on approved DMP and update the team as necessary. · Coordinate and participate in departmental/corporate task forces and committees (as needed). · Make client presentations (as requested). · Assist in developing Biometric workflows and oversee Biometric Central File System. · Import and modify standard reports for protocol specific database per DMP. · Provide support or perform data management tasks (as needed) to support personnel, projects, deliverables, and deadlines. · Identify, document, and follow up on out of scope Clinical Data Management issues. · Communicate with all departments regarding project status/issues. · Provide ongoing feedback on DM workflows and technologies to increase efficiency and provide data feedback to CRAs. · Bachelor’s degree in a scientific discipline. · 5+ years industry Clinical Data Management experience along with 3 years of direct management experience. · 5+ years SAS and relational database programming experience. · Detailed experience with coding dictionaries (WHO, COSTART MedDRA). · Experience in ORACLE and EDC. · Proficiency in SAS, Microsoft Word, MS SQL Server or Access, Excel, PowerPoint, PageMaker, Coding dictionaries and auto encoders. · Ability to handle multiple projects and work in a team environment. · Strong organizational, communication and prioritization skills. · Excellent written and verbal communication skills. |
