Responsibilities

The Senior Project Manager will manage clinical research studies to ensure adherence to approved scopes of work, budgets, ICH GCP guidelines, and FDA regulations, serving as the study lead and primary contact for sponsors. They will supervise and provide support to the Clinical team, create and review clinical study documents, drive clinical teamwork and communications, manage subject accrual and retention, assist in TMF management, prepare for audits and inspections, and present study status updates and reports to sponsors. Additionally, the role involves training Associate CPMs, providing high-level guidance, generating monthly billing information, and participating in various meetings and performing additional duties as assigned.