*Possess 14 years of clinical research experience and current GCP certification*Exercises strong analytical skills to identify customer needs and ensure satisfaction with deliverables*Demonstrates keen insight and decision-making ability to effectively resolve regulatory issues*Exhibits professional verbal and written communication skills *Utilizes Excel, Adobe Acrobat XI Pro, SharePoint, CTMS, Veeva Vault eTMF, Trial Interactive eTMF, iMedidata RAVE & CTMS, IRT, Wordbee*Experience with regulatory essential documentation development and review, CIRB submission, eTMF, investigator site payments, vendor management, translation management system, and global clinical supplies.