Manager,ClinicalTrials

POSITION SUMMARY: The Manager, Clinical Trials will be responsible for managing all aspects of clinical trials from start-up through close-out. The Clinical Trial Manager should have experience in managing all aspects of the trials independently, and is expected to provide functional expertise to ensure that study timelines, costs and quality metrics are met and the study is conducted in compliance with the study protocol, SOPs, and applicable regulatory requirements. PRIMARY RESPONSIBILITIES: Manage the execution and conduct of all aspects of very complex clinical studies to ensure that timelines, cost, and quality metrics are met Responsible for selection of vendors/CROs and provide effective ongoing management to vendors/CROs working on the project to ensure compliance and execution of project deliverables within the approved budget, study timeline, and study protocol. Works closely with investigative site personnel, CROs, and other study vendors Manage study contracting, budget, forecasting, accruals and payment process for all clinical trial vendors including investigational sites Lead study-related activities such as protocol and informed consent preparation, investigator selection, study training material development and delivery, monitoring plans development and execution, CRFs, design and completion, TMF maintenance, protocol amendment and clinical report preparation, as required Collaborate with Clinical Data Management group to ensure correct CRFs content is collected, prepare comprehensive completion guidelines, and design effective data listings and study reports Train CROs, vendors, investigators and study coordinators on implementation of study protocol Hire, train, manage and oversee Clinical trial staff, and serve as a resource for others within the company for clinical trials management expertise Monitor and track clinical trial progress and provide status update to stakeholders Support sample management and prospective sample testing for studies w