Neurocrine Biosciences
Clinical Trials Manager
US CA San Diego · Senior
Sponsorship not specified$131k-$179kDetected 2 days ago
Project ManagementVendor ManagementClinical TrialsClinical ResearchFDA RegulatoryResearchExperimental DesignLeadershipCommunicationCollaborationProblem Solving
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odds of building a lasting career here
57Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level III)83
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~45% per draw at Level III). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
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Files H-1B transfers
6 transfer filings in the last year, covering 6 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.
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About the role
- 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
- Your Contributions (include, but are not limited to):
Responsibilities
- Participates in technical and study design discussions and provides input to clinical trial outlines, protocols, and clinical study reports
- Leads and manages the operational activities to support planning, initiation, conduct and close out of assigned Clinical Studies (domestic and global studies).
Requirements
- BS/BA degree AND 6+ years of clinical trial management experience, including CRO/vendor management (domestic and international), monitoring of budget scope, clinical site monitoring or related experience required.
- Master's AND 4+ years of related experience
- Must have detailed knowledge of clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directive
- Excellent knowledge of clinical operations, specifically conducting clinical studies from start-up through close-out
- Strong understanding of Clinical Research industry and the relevant environments in which it operates
- Ability to identify and organize clinical resources needed to accomplish tasks, set objectives and provide clear direction to others
- experience planning activities in advance and taking account of possible changing circumstances
- Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
Compensation
- The annual base salary we reasonably expect to pay is $130,800.00-$179,000.00.
Company info
- 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:
- Leads and manages the operational activities to support planning, initiation, conduct and close out of assigned Clinical Studies (domestic and global studies). Manages studies using Contract Research Organizations (CROs) as well as managing internally run studies. _
- 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 )
- Biosciences is a leading biopharmaceutical company with a simple purpose:
- to relieve suffering for people with great needs.
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