Description
The National Institutes of Health (NIH) is seeking a contractor to provide clinical data management, statistical analysis, regulatory support, and data quality oversight for pediatric clinical trials conducted under the Best Pharmaceuticals for Children Act (BPCA) program. The contractor will be responsible for establishing and maintaining state-of-the-art data capture, data sharing, and data quality oversight processes to integrate and manage data from clinical trials conducted across multiple clinical specialties and sites. The contractor will also be responsible for ensuring the integrity of collected data and compliance with FDA and NICHD requirements governing the conduct of clinical and preclinical studies. Some of the key responsibilities include:
• Developing a transition plan to archive data and trial master files for approximately 40 closed studies
• Establishing and managing a data collection, data analysis, and data storage system for pediatric clinical and preclinical activities
• Leading and performing regulatory activities associated with BPCA-related Investigational New Drug (IND) applications and New Drug Applications (NDAs)
• Developing, coordinating, and maintaining a BPCA Data Safety Monitoring Plan
• Conducting clinical site monitoring, training, and auditing necessary for protocol implementation and data quality review
• Providing statistical leadership for the analysis of clinical trial data for FDA submission
• Participating in the BPCA Consortium Steering Committee and coordinating logistics for committee meetings, conference calls, and related activities.