Just in Time GC

Jim Markley

Project Lead
Just in Time GC

Jim Markley is currently a Project Lead at Just in Time GCP where he is responsible for leading GCP
projects related to eClinical systems and inspection readiness activities. Jim utilizes his 7 years of GCP
experience working both at a study site and a large CRO, to take a more holistic approach to managing
these projects. He has a wide array of experience in assisting his clients through TMF system
implementation & validation, process implementation, completeness reviews, and inspection readiness
efforts. At Just in Time GCP, Jim has assisted multiple organizations in the preparation and conduct of
mock inspections. His experiences have taught him what it takes to be inspection ready, regardless of
whether the study is newly completed or an older study supporting a newer submission.  Jim received his
Bachelor’s Degree from Penn State University.

Jim Markley’s Session(s)

3:00 pm
Inspection Preparation when the TMF Falls short of Inspection Ready

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