Director Of Clinical Operations

Confidential   Irvine, CA   Full-time
Posted on July 05, 2020
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Director of Clinical Operations: Lead & manage the execution of multiple ongoing clinical oncology drug development studies occurring in multiple locations around the world by directing Clinical Trial Managers to plan and implement each of their respective studies per his/her recommendations. Make high-level decisions regarding the planning & implementation of these studies based on information the Clinical Trial Managers provide. Approve documents for submission to regulatory agencies. Monitor clinical trial progress through communications with Clinical Trial Managers. Direct Clinical Trial Managers to ensure studies are conducted in accord w/Standard Operating Procedures (SOPs), Good Clinical Practice (GCPs) processes, and ICH (International Conference on Harmonization) guidelines, by providing them with guidance in these areas. In collaboration with the Sr. Director or Department VP, make the final decision on the hire of staff. Work collaboratively w/cross-functional teams, by directing them to implement clinical trials consistent w/company strategic plan. Responsible for training of Clinical Trial Managers on various topics including adverse event reporting. ensure investigator compliance with study protocol, ICH-GCP & applicable regulations. Oversee operational aspects of clinical research projects by managing Clinical Trial Managers. Direct clinical trial workflow. Supervise Clinical Trial Managers. Job location: Irvine, CA. Send CV to Spectrum Pharmaceuticals, Inc., 11500 S. Eastern Ave. #240, Henderson, NV 89052


Irvine, CA