Open Roles
This position requires a candidate with extensive experience in 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 support regulatory approvals and key strategic evidence initiatives.
As a member of the Clinical Affairs team, you 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. You will work closely with clinical research associates (CRAs), clinical trial assistants (CTAs), and data management for study conduct and execution.
During trial execution, drive progress during site selection, site start-up, and through enrollment and follow-up. Clearly provide guidance to monitors about monitoring needs and oversee compliance work on the study. Take a leadership role in external communication with investigators and study teams.
Work with biostatisticians to review and interpret results of clinical studies, develop clinical study reports, and help develop clinical publications. The ideal candidate will have experience managing premarket studies in the United States and utilizing resources to research and scope research topics.