CLINICAL STUDY MANAGER / SR. CLINICAL PROJECT COORDINATOR

Our client is a human health care ( hhc ) company seeking innovative solutions in disease prevention, cure and care for the health and well-being of people worldwide. The company marshals its talents to explore new therapeutic approaches that address two key goals: meeting the medical needs of patients and their families, and improving their quality of life. Currently, the company is looking to add a Clinical Study Manager / Senior Clinical Project Coordinator to their growing and dynamic team. 
The purpose of the job is to oversee the clinical monitoring/management of one or more major programs within a therapeutic area. The Study Manager / Sr. CPC will also be responsible for mentoring Junior Clinical Project Coordinators. The candidate will Manage and monitor CROs/sites through primary or secondary monitoring. Participate in the development and/or review of protocols, informed consents, CRFs, contracts, regulatory documents, labeling, advertisement, etc. Attend and actively participate in project and study related meetings. Work with study director/project management to develop timelines. Participate in the identification and selection of qualified CROs, study sites and help to facilitate the contracting processes. Participate in and work with the data manager in the data review and data query processes. Provide key monitoring information to be benchmarked, tracked, analyzed and improve upon with respect to quality, speed and efficiency. Work with QA on coordinating audit/audit responses for clinical studies.