Senior Clinical Data Manager

The Senior Data Manager brings advanced understanding of the clinical data management process from study start-up through database lock, overseeing compliance activities across multiple CROs as it relates to data management.

Requirements

• Minimum of 8 years data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.
• Proven track record of strong project management skills and experience managing data management activities for large drug development programs.
• Experience with all phases of development in one or more therapeutic areas preferred.
• Ability to handle multiple development programs simultaneously.
• NDA/CTD Experience preferred.
• Strong knowledge of data management best practices & technologies as applied to clinical trials.
• Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
• Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.