Clinical Study Manager
BioPhase Solutions - San Diego, CA

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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

PRIMARY RESPONSIBILITIES:
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

investigator recruitment

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)

QUALIFICATIONS:
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) years’ experience with design and execution of related oncology trials.

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