Senior Manager, Clinical Programming

Job Summary

To ensure data quality and compliance across clinical programs, the full-time Senior Manager, Clinical Programming will establish SDTM standards, oversee programming activities with vendors, and serve as a subject matter expert on data standards in a remote environment.

Key responsibilities

• Develops and implements SDTM standards ensuring compliance with CDISC and industry regulations
• Reviews study eCRFs and provides guidance on SDTM mapping to align data collection standards
• Facilitates continuous improvement of standards processes and serves as a liaison between Clinical Programming and External Data Management

Required qualifications

• Bachelor's degree in Statistics, Computer Science, or Life Sciences; Master's degree preferred
• 6-8 years of relevant experience in pharmaceutical, biotech, CRO, or regulatory environments
• Proficient in SAS programming with practical knowledge of R for clinical trials
• Demonstrated knowledge of clinical research, metadata management, and regulatory requirements
• Experience managing complex projects and working with cross-functional teams