Clinical Data Manager

6 days ago


franklin lakes, United States Katalyst Healthcares & Life Sciences Full time

Responsibilities: Manage all data management activities according to quality standards and regulatory requirements, ensuring adherence to project timelines and budget. Oversee the development of CRFs and CCGs with other functional area representatives, ensuring all data management databases are developed and validated. Manage interactions and deliverables with third-party vendors and CROs, ensuring proper execution of data management activities and providing relevant metrics to the study team. Monitor outsourced data management activities for efficiency and regulatory compliance, providing feedback on vendor selection. Review and provide input on protocols, SOPs, and work instructions for the data management department. Perform ongoing review of study documentation in the trial master file to ensure audit readiness. Perform other related duties as required and assigned. Requirements: Bachelor's degree or equivalent combination of education. 4+ years of relevant experience in clinical data management within biotech or pharmaceutical/drug development. Preferred experience in vendor management and global operations. Strong planning and project management skills, including risk assessment and contingency planning. Effective communication and interpersonal skills. Excellent organizational and problem-solving skills with attention to detail.



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