-Responsible for the development of CIPs, study plans, clinical data analysis review, ICFs, CRFs, clinical site study material, and clinical databases-Oversee clinical meetings such as Investigator, Steering Committee, DSMB, etc.-Responsible for study budget, timeline, resource, and risk mitigation ongoing review to ensure completion of the study according to forecast-Responsible for overseeing deliverables of monitoring, DM, biostats, and CRAs through all study phases-Manage external vendors including CROs, Core Labs, IVRS, Biostatiscians, etc.-Perform SQVs, SIVs and COVs, review and audit data collection forms-Review and approve monitoring reports.-Responsible for contracts and budget terms for the clinical study-Responsible for ensuring successful completion of clinical site audit activities (corporate and regulatory), including pre-inspection training at clinical sites -Responsible for timely completion of periodic clinical reports and modules for regulatory submissions including 510(k), PMA, IDE, etc.-Responsible and provide support for site and sponsor BIMO audits including review of site and sponsor 483 response.-Lead CAPA activities in response to sponsor issued 483 including authoring of FDA response.-Responsible for facilitating and authoring deficiency responses to FDA.-Ensure departmental compliance as well as appropriate departmental resources are available to effectively maintain the quality system (people, facilities, tools, and training)-Responsible for the development, maintenance, and execution of SOPs for clinical investigations and all other applicable regulatory -Lead and interface with KOLs, study investigators, and all external study research personnel-Provide study updates and risk mitigation strategy recommendations to senior leadership team-Represents the clinical organization on cross-functional teams (e.g., R&D product development, work stream teams, etc.)-Direct management of CRAs and CPCs