Clinical Trial Manager
CurrentManage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations.Serve as primary Sponsor contact for operational project-specific issues and study deliverablesMaintain in depth knowledge of protocol, therapeutic area, and indicationProvide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is providedReview and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicableDevelop operational project plansManage risk assessment and executionResponsible for management of study vendorsManage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables.
