BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Clinical Study Manager to work for a leading San Diego biotechnology company.
Clinical Study Manager
management of oncology trials according to ICH, GCP and FDA requirements
project management, including site, CRO, and Vendor
monitoring the progress of trials including enrollment
development of protocols, consent forms, and IRB materials
case report form development And EDC
data cleaning and database locking
supervision of clinical research associates (CRAs)
Undergraduate degree in life sciences
At least 5- of relevant oncology experience in clinical research management in pharmaceutical company or CRO including trial set-up, monitoring, and close-out (Phases 1-3)
project management skills, successfully managing multiple projects, trials, and priorities
Ability to work with global teams
Experience in practical knowledge and implementation of ICF-GCP guidelines and US and ex-US regulations
Experience with electronic data capture and data management software
Experience in the management of CRAs
MINIMUM EDUCATION AND EXPERIENCE:
B.S. in Biological Sciences or related scientific discipline, including a minimum of five (5) yearsâ€™ experience with design and execution of related oncology trials.
BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. The goal of BioPhase is to...