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 (include, but are not limited to):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 policiesServes as primary point of contact for clinical operations aspects of assigned clinical studiesParticipates in technical and study design discussions and provides input to clinical trial outlines, protocols, and clinical study reportsManages contract research organizations (CROs) and other contract service providers (CSPs) for assigned studiesLeads 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 necessaryWorks collaboratively with clinical operations department in developing, implementing and enforcing NBI standard processes across all clinical programsOther duties as assignedRequirements: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. ORMaster’s AND 4+ years of related experienceMust have detailed knowledge of clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU DirectiveExcellent knowledge of clinical operations, specifically conducting clinical studies from start-up through close-outBroad trial management protocol and process knowledgeStrong understanding of Clinical Research industry and the relevant environments in which it operatesAbility 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 effectivelyHas knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplinesWorks to improve tools and processes within functional areaDeveloping reputation inside the company as it relates to area of expertiseAbility to work as part of and lead multiple teamsExhibits leadership skill and ability, typically leads lower levels and/or indirect teamsExcellent computer skillsExcellent communications, problem-solving, analytical thinking skillsSees broader picture, impact on multiple departments/divisionsAbility to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiencyExcellent project management skillsProven 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 efficientlyProven ability at analyzing data and information to derive conclusions and drive sound decision makingNeurocrine 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.SummaryLocation: UK LondonType: Full time
Clinical Trials Manager employer: Neurocrine
Neurocrine Biosciences is an exceptional employer, dedicated to fostering a collaborative and inclusive work culture that empowers employees to make a meaningful impact in the biopharmaceutical industry. Located in London, we offer competitive benefits, opportunities for professional growth, and a commitment to employee well-being, ensuring that our team members thrive while working on groundbreaking treatments for complex neurological and psychiatric disorders.
