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Sr. Clinical Trials Manager
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$155,000 - $165,000 a year
Full-time
- Our lead program, AlloNK®, is an allogeneic, non-genetically modified NK cell therapy candidate designed to enhance the activity of monoclonal antibodies or NK cell engagers.
- The Senior Clinical Trials Manager is responsible for oversight and execution of the operational aspects of one or more clinical studies from protocol development through database lock.
- Ensures timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations and guidelines governing the conduct of clinical trials.
- The Senior Clinical Trials Manager provides oversight of the CRO and other third-party vendors on their assigned study as well as expertise to internal teams (regulatory affairs, medical writing, biometrics, pharmacovigilance, and product manufacturing) to ensure quality processes and deliverables.
- Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures.
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