Independently manages multi-center clinical trials. Takes ownership of projects to assure proper planning, timely initiation/completion and high quality documentation. Provides key coordination role with the Sponsor, sites, CRAs, Recruitment Management, Quality Assurance, Data Management and Medical Communications departments.
- Manages all activities related to multi-center trials
- Communicates with the project team (Sponsor, CRAs, CTAs, data management, central labs, etc.)
- Coordinates monitoring visits and reviews monitoring reports
- Conducts monitor training meetings (prepares agenda and reviews minutes)
- Conducts feasibility (interviews investigator and/or CRC, assesses investigator’s ability to meet enrollment requirements, etc.)
- Selects sites
- Negotiates investigative site budgets
- Negotiates Clinical Trial Agreements with the investigator/legal department
- Functions as primary communicator with investigative sites
- Annotates Case Report Forms and provides completion guidelines
- Creates source documents
- Plans and manages investigators’ meeting
- Reviews and queries data documented on Case Report Forms
- Maintains study timelines
- Conducts team meetings (prepares agenda and reviews minutes)
- Oversees transfer of data between Quality Assurance, Data Management and Investigative sites
- Oversees Clinical Trial Associates and Assistant Clinical Project Managers
4 year degree, preferably in a life science field, with at least 3 years of CRO project management experience. Strong diabetes and/or GI experience is a plus.