ProKidney

This role is responsible for maximizing site performance and site engagement in clinical studies by leveraging strong clinical operational and therapeutic expertise. This role engages with clinical sites to develop, build, and maintain strong relationships with investigators/staff that will ensure high-quality investigative sites to support clinical development programs. Provides operational support to deliver the study within planned timelines and according to required standards of quality and compliance.

The IT Assurance and Compliance Manager ensures all GxP computerized systems are implemented, validated, and maintained in compliance with regulatory and industry standards. This role leads validation efforts for new software implementations, manages the lifecycle of validated systems, and ensures sustained compliance through continuous monitoring and governance. This role combines technical expertise in computer system validation, a strong understanding of quality systems, and excellent cross-functional collaboration skills.