Associate Specialist, Clinical Trials Operations

Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)

About the Role:

Supports and assists the centralized operational activities for assigned Clinical Studies. Centralized activities can include but are not limited to set up of studies, development of Informed Consent documents and study plans, handling IRB submissions of protocol/ICF/sites, management of the Trial Master File (TMF) and Financial Disclosure Forms, feasibility and selection of sites, coordination of committees (i.e. adjudication committees), support of site enrollment, and oversight of monitoring for studies outsourced to Contract Research Organizations (CROs).

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Your Contributions (include, but are not limited to):

• Assists to ensure that centralized activities for 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

• Works collaboratively with assigned study teams in developing, implementing and ensuring NBI standard processes across clinical programs

• Assists with administrative support in the development of processes, tools, templates, and applicable training related to centralized activities and/or monitoring oversight

• Supports generating metrics and reports to provide insights into cycle time for centralized activities and/or oversight of outsourced monitoring activities

• Works collaboratively within clinical operations in documenting NBI standard processes across clinical programs

• Supports inspection readiness activities

• Other duties as assigned

Requirements:

• BS/BA Degree AND Some relevant experience

• Some knowledge of clinical operations, specifically conducting clinical studies from start-up through close-out

• Some trial management protocol and process knowledge

• Good computer skills

• Developing communications, problem-solving, analytical thinking, planning and organization skills

• Ability to work as part of a team

• Some clinical terminology and GCPs knowledge

• Some knowledge of clinical drug development proce