Senior Manager, Technical Standards

Job Summary

Serving as a key liaison for the Data Standards organization, the full-time Senior Manager, Technical Standards will manage collaborations with Clinical Data Engineering and IT to enhance data standards, oversee system operations, and develop tools for data integration, all while working in a hybrid onsite/remote capacity.

Key responsibilities:

• Establish tools for end-to-end data lineage and impact assessments for standard objects
• Collaborate with cross-functional teams to implement technology solutions for standards automation and governance management
• Oversee system operations, including user access management and technical implementation across various platforms

Required qualifications:

• 8 years of experience with a BS degree in Biostatistics/Computer Science or equivalent, or 4 years with an MS degree, or 2 years with a PhD
• Experience in multiple phases of clinical trials across various therapeutic areas
• Proficient knowledge of CDISC standards, FDA & ICH regulations, and clinical data management
• Experience with AI-assisted development and proficiency in R or Python
• Demonstrated ability to manage complex projects and work with cross-functional teams