JobMesh

Clinical Affairs Specialist *PC 1610

Miltenyi Biotec · Gaithersburg, Maryland, US

Your Role: This position is primarily responsible for managing projects and programs that support the development of Phase I cell therapies with our academic...

Job description

Your Role: This position is primarily responsible for managing projects and programs that support the development of Phase I cell therapies with our academic partners. This role will also be responsible for supporting the implementation of projects to PMO global standards, Miltenyi business processes, strategic initiatives, and best practices to meet project goals. Support the leadership team in the development of project alignment, with the portfolio, to business strategy, functional constraints, and resource proficiency. The role applies professional expertise and company policies to resolve issues, determine appropriate actions, and refine processes as needed. Requirements: - Aid in the execution of the Phase I clinical trials from protocol design to the final clinical study report. - Execute high quality, integrated cross-functional plans for the project/clinical trial. - Coordinate the activities of functional groups that comprise the clinical department team for the product including, but not limited to clinical monitoring, data management, statistics, medical writing, medical monitoring, and safety to insure proper conduct and timely completion of all projects. - Apply best...