The position requires a minimum of 5 years of experience in the clinical research field, particularly clinical supplies management, services delivery, and eClinical systems implementation or equivalent.
Knowledge of US FDA Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) GCP regulations, Electronic Records; Electronic Signatures regulation (21 CFR Part 11) and EU Annex 11, and associated regulatory guidance documents is desired.
Education and/or Certification Requirements:
The candidate must possess at minimum of a bachelor’s degree in life sciences, supply chain management, or information technology field, or equivalent experience.
Other Skills / Requirements: