Neurocrine Biosciences
Clinical Trials Manager
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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
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.
Your Contributions
- 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
- Works collaboratively with clinical operations department in developing, implementing and enforcing NBI standard processes across all clinical programs
- Other duties as assigned
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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. OR
- 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
- Broad trial management protocol and process knowledge
- 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; manages time effectively
- Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
- Works to improve tools and processes within functional area
- Developing reputation inside the company as it relates to area of expertise
- Ability to work as part of and lead multiple teams
- Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
- Excellent computer skills
- Excellent communications, problem-solving, analytical thinking skills
- Sees broader picture, impact on multiple departments/divisions
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
- Excellent project management skills
- Proven ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback; experience productively partnering cross functionally and with customers to advance work effectively and efficiently
- Proven ability at analyzing data and information to derive conclusions and drive sound decision making
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Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.
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