Experienced Clinical Research Data Manager with a robust background in managing and optimizing clinical research infrastructure for novel cell and gene therapies. Demonstrated expertise in ensuring data quality, regulatory compliance, and effective collaboration within multidisciplinary teams. Proven track record in previous roles, including comprehensive claims management, auditing within the healthcare insurance industry, and exceptional customer service and pharmacy operations management.
Strong knowledge of clinical data management processes, systems, and regulations
Proficiency in Veeva and CTMS EDC applications
Experience in developing and implementing data management plans and protocols
Familiarity with relevant industry standards including FDA and HIPAA regulations
Strong analytical skills and attention to detail
Excellent communication and interpersonal skills with ability to effectively present data and findings to stakeholders
Experience in data cleaning and query management
Ability to manage multiple tasks and priorities in fast-paced environment
Proficiency with Microsoft Office software application (Excel, PowerPoint, Word, Outlook, OneNote), Adobe, and Tableau