Clinical Contracts Manager

Employment Type

: Full-Time


: Miscellaneous

Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve patient suffering and enhance lives. What We Do: Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with 28 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, with three pivotal and five mid-stage clinical programs in multiple therapeutic areas. Headquartered in San Diego, Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. (*in collaboration with AbbVie) About the Role: Responsible for leading the development of clinical site budgets including review, adjustment, and negotiation with clinical sites. Interacts closely with legal department to ensure clinical contracts are fully executed in a timely manner. Manages administration / execution of clinical contracts (invoicing, timelines, issues, etc.) across multiple projects. _ Your Contributions (Include, but not limited to): * Supports clinical trial contractual negotiations to ensure appropriate business and legal terms, including triaging, reviewing, identifying issues for escalation and recommending contract language * Manages and ensures on-time processing of all clinical contracts from initial request through execution in accordance with the project timelines * Provides both legal and clinical operations support in managing clinical contracting activities across multiple projects * For studies that are outsourced, manages CRO contracts, site and budget agreement activities and serves as a primary contract and budget liaison between CRO, company legal and clinical operations * Develops Clinical Trial Agreement (CTA) template and budget grid for clinical studies * Oversees the CTA start-up process. Sends CTA template, budget grid and supporting documentation to sites and serves as primary contact with sites for contracts. Submits web requests and coordinates with Legal Department on execution of CTAs * Collaborates with Head of Clinical Operations (or designee) in processing work orders, service agreements, consulting agreements, license agreements, MSAs and CDAs * Negotiates budgets with clinical sites based on parameters defined by Head of Clinical Operations (or designee) * Collaborates with finance/accounting departments in support of contract budgets * Manages invoices associated with clinical trials and ensures payments are made based on executed contracts * Contributes to the development and organization of contracting and budget/payment processes * Mentors less experienced team members on clinical accounting and administrative contract duties * Other duties as assigned Requirements: * BS/BA degree in business administration or health care/science related field and 8+ years of experience in a CRO, Biotech or Pharmaceutical organization. Experience with contract management, negotiation, budgeting and administration including billing/invoicing, issue resolution, point of contact for CRO OR * Master's degree in business administration or health care/science related field and 6+ years of similar experience noted above * Knowledge of Clinical Trial process, regulations and guidelines * Ability to work effectively across a matrix organization * Ability to prepare/negotiate external provider master service agreements, work/change orders, etc. and track for clinical operations * Ability to read and interpret contracts, ensure contract language / terms meet company standards * Strong contract administration skills, including budgeting, billing/invoicing, issue resolution, point of contact for CRO * Knowledge of clinical contract accounting and budgeting process * Solid understanding of drug development and clinical operations * 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 and organizational skills * Excellent interpersonal and communication skills and experience supporting multiple teams * Strategic thinker who is able to identify issues and improve processes * Ability to work effectively across a matrix organization * Advanced knowledge in Microsoft Word and Excel #LI-TM1 Neurocrine Biosciences is an EEO/AA/Disability/Vets employer. As a condition of employment with Neurocrine Biosciences, Inc. in the United States, you must be fully vaccinated for COVID-19 and provide valid proof of vaccination to the company.

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