Clinical Data Manager Full-time Job

Clinical Data Manager

#clinicalresearch #clinicaltrials #clinicaldataanalyst #REGULATORYaffairs #medicalcoding #medicalbilling #research #healthcare #medicalresearch #clinicaltrial #science #clinical #health #clinicalstudies #pharma #medical #pharmacy #biotech #clinicareers #pharmacovigilance #pharmaceuticals #clinicalstudy #pharmacovigilance #medicalaffairs #clinicalresearchassociate #pharmaindustry #doctor #phd #oncology #drugdevelopment #cra #biotechnology # Job Responsibilities: Provide operational leadership of data management tasks fall MTEM-sponsored clinical trials from start-up to close-out (including but not limited to eCRF design & edit checks, data capture/completion guidelines, work instruction manuals, SOPs, UAT, project specific data management plans, data review & reporting, medical coding, data import/export, transformation to SDTM, database lock). Ensure adequate documentation and application of internal and industry standards/best practices across studies. Perform quality control audits to ensure accuracy, completeness, proper ge of clinical systems and data. Generate data queries based on validation checks errors and omissions identified during data entry to resolve identified problems Oversee CROs and vendors fall data management related activities, providing consistent team direction/guidance and monitoring quality of work through key performance metrics. Manage timelines fdata management activities such as to planned data cuts, data transfers, database cleaning and freezing. Represent Data Management at cross-functional team meetings providing accurate study status updates and proactive communication/escalation of data management issues and risks. Participate in Data Management department infrastructure, by contributing to SOPs/work instructions Developerpment, CRF standards Developerpment and cross-functional process improvement initiatives. Support Project Management and Contracts on DM budget-related activities. Mentother team members as applicable, and any other duties as assigned. Evaluate processes and technologies, and suggest revisions to increase productivity and efficiency Requirements: Bachelor's degree in the scientific, life sciences, computer sciences, mathematics field related field, required. Advanced degree is preferred. Minimum of five years of Clinical Data Management and hands-on experience with SDTM programming in the pharma/biotech industry. Strong oncology trial experience preferred.