Clinical Trials Manager

About The RoleLeads 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 goalsIdentifies 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-out.Broad 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.The annual base salary we reasonably expect to pay is $130,800.00-$179,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.