Senior Regulatory & Start Up Specialist, cFSP

Job Overview

Regulatory & Start Up Specialist, cFSP.

Location: Mexico - Full home based

This position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a point of contact for investigative sites and the study team members. This includes supporting site qualification, site level regulatory green light and site maintenance/close-outs.

Essential Functions

• Participate in development of in-house model process documents.

• For assigned sites and countries, serve as a primary site contact for end-to-end study activity.

• Participate in all assigned Study Site Management study team meetings, providing cross-functional teams with detailed updates related to study and site activity.

• Utilize systems and tools to track assigned activities and produce reports and metrics as needed.

• Oversee essential document col...