Teams at Parexel

This role involves leading CMC regulatory strategies for global product lifecycle activities, authoring documentation, and managing submissions across international markets.

Accountable for planning, coordination, and conduct of clinical trial activities per ICH-GCP. Manage trial documentation, systems, supplies, submissions, TMF, and reporting. Support cross-functional and regional teams, ensure regulatory compliance, monitor trial progress, implement corrective actions, and contribute to quality oversight and process improvements.

Lead and support site start-up and activation for assigned studies: compile Investigator Initiation Packages, coordinate regulatory and ethics submissions, update clinical trial systems, manage cross-functional activities, resolve site issues, and ensure compliance with GCP, sponsor standards, and study timelines.