• This position requires a candidate with extensive experience helping evidence generation strategy and execution of clinical studies. • The Clinical Study Manager-4 (CSM IV) role will develop and execute strategies for clinical and outcomes research studies to help regulatory approvals and key strategic evidence initiatives. • As a member of the Clinical Affairs team, this role will be accountable for working with key stakeholders to design and develop clinical protocols and execute clinical studies (pre-market or post-market studies), with minimal supervision. • The candidate will be required to work closely with clinical research associates (CRAs), clinical trial assistants (CTAs) and data management for the conduct and execution of the study, as well as with biostatisticians to review and interpret results of clinical studies, develop clinical study reports, or help the development of clinical publications. • During trial execution, the CSM will drive the progress of the trial during site selection, site start-up and through enrollment and follow-up. • The CSM will clearly provide guidance to the monitors about monitoring needs, and oversee compliance work on the study. • The CSM will also take a leadership role in external communication with investigators and study teams.