
Clinical Trials Manager
Ensures clinical studies are conducted in compliance with Food and Drug Administration (FDA) regulations, EU Directive, International Conference on Harmonization (ICH) guidelines, and NBI Standard Operating Procedures (SOPs) and policies. Serves as primary point of contact for clinical operations aspects of assigned clinical studies. Participates in technical and study design discussions and provides input to clinical trial outlines, protocols, and clinical study reports. Manages contract research organizations (CROs) and other contract service providers (CSPs) for assigned studies. Leads study team meetings and manages study issues. Develops and manages study timelines in accordance with corporate goals. Identifies barriers to enrollment and develops recruitment solutions. Manages internally run studies (without CROs) including the management of CRAs and develops monitoring plans, on-site monitoring guidelines, forms, tools and performs onsite monitoring and co-monitoring visits, as necessary.
8+ years of clinical trial management experience
Broad trial management protocol and process knowledge
Strong understanding of Clinical Research industry and the relevant environments in which it operates
Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
Project Management
Vendor Management
Time Management
Monitoring of budget scope
Clinical site monitoring
Multitasking
Process Improvement
Detail Oriented
Communication Skills
Problem-Solving
According to JobzMall, the average salary range for a Clinical Trials Manager in 12780 El Camino Real, San Diego, CA 92130, USA is $83,355 - $130,417. This is based on current salaries submitted by employers and anonymous employees to JobzMall.
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Neurocrine Biosciences is a publicly traded biopharmaceutical company founded in 1992. Neurocrine develops treatments for neurological and endocrine-related diseases and disorders. In 2017, the company's drug valbenazine (Ingrezza) was approved in the US to treat adults with tardive dyskinesia (TD). The company is also developing treatments that are in various stages of clinical research for Parkinson's disease, Tourette syndrome, and congenital adrenal hyperplasia and with a partner for endometriosis and uterine fibroids.

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