The Senior Clinical Trial Manager is responsible for the management of clinical trials from study start-up activities through the clinical study report. This position works primarily with CRO's and external vendors as well as with various internal team members to drive to completion all study deliverables in a fully compliant fashion. This role will ensure the highest level of data quality and compliance to quality standards and regulatory guidance; proactively identify, communicate and resolve clinical study operational issues; and participate in process improvement initiatives as required.
o Direct and manage CRO interactions, including sponsor oversight of all clinical operations activities (e.g., study management, monitoring, site management, trial master files, etc.)
o Work with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
o Manage Clinical Operations personnel within the company and CRO's, as needed
o Oversee CRO activity including but not limited to the clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
o Support sponsor oversight of adverse event reporting, safety reporting and pharmacovigilance requirements required for global clinical trials