Sr. Clinical Trials Manager

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: Contribute to overall clinical trial strategy and responsible for managing the operational activities to support planning, initiation, conduct and close out phases of clinical studies. Leads and manages the end-to-end operational activities of assigned Clinical Studies (domestic and global studies). Manages studies using multiple Contract Research Organizations (CROs) as well as managing internally run studies. Responsible for integrity of clinical trial data and completeness of Trial Master File (TMF) documentation. _ Your Contributions (include, but are not limited to): Responsible for developing, leading and managing NBI trials on an end-to-end basis and contribute to the overall trial study strategy and planning Serves as primary point of contact for clinical operations aspects of assigned clinical studies, may oversee other clinical trials assigned to lower level team members Participates, and may lead, in technical and study design discussions and provides expert level counsel and input to clinical trial outlines, protocols, and clinical study reports Manages multiple contract research organizations (CROs) and other contract service providers (CSPs) for assigned studies Oversees 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 trial monitoring team(s) and develops various study plans, on-site monitoring guidelines, forms, tools and performs onsite monitoring and co-monitoring visits, as necessary Works collaboratively with clinical operations department in developing, implementing and enforcing NBI standard processes across all clinical programs Manages Trial Master File (TMF) content ensuring all study documents are appropriately filed and inspection ready throughout the conduct of the study as well as at study completion 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 Incorporates Risk Based Monitoring with Clinical Quality Assurance counterparts to assure subject safety and data integrity across NBI Development Programs May support the recruitment, training, management, and career development of subordinates within the clinical operations group Other duties as assigned Requirements: BS/BA degree AND 8+ years of clinical trial management experience, including CRO/vendor management (domestic and international), monitoring of budget scope, clinical site monitoring or related experience required. OR Master’s AND 6+ years of similar experience noted above