Project Manager/Sr. Project Manager, Clinical Operations
As a key member of the clinical operations team, the successful candidate will be responsible for planning, day-to-day operations and vendor management of one or more clinical programs, and providing operational expertise to cross-functional project teams. Core responsibilities include interfacing with the client and project staff, including task managers who oversee the day-to-day operation for multiple functions with constantly shifting priorities and strict project timelines, tracking study progress and managing critical clinical study timelines, while ensuring project quality and compliance with FDA Regulations and with client policies.
Requirements include B.S. degree (Masters a plus) with 10-12 years of clinical research experience and a minimum of 5 years of proven project and line management experience in the pharmaceutical/ biotechnology industry or with a CRO, working knowledge of FDA/EMA and other regulatory requirements, GCPs/ICH guidelines; and hands on regulatory, clinical operations, or clinical trial monitoring experience. Demonstrated ability to take a leadership role and drive quality progress. A background in Infectious Disease/HIV clinical trials and/or Oncology is preferred. Experience in the conduct of Phase 1 protocols or prior work on a government contract, e.g., NIH, CDC, DoD, is a plus.