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 suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. Our portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, congenital adrenal hyperplasia, endometriosis* and uterine fibroids*, and a pipeline of compounds in clinical development. For three decades, we have applied our neuroscience insight to treat complex conditions, relentlessly pursuing medicines to ease the burden of debilitating diseases because you deserve brave science. For more information, visit neurocrine.com and follow us on LinkedIn, X, and Facebook. ( *in collaboration with AbbVie ) About the Role: The TMF Document & Clinical System Associate Specialist provides operational support and maintenance for clinical systems including eTMF and CTMS. Assists in managing documentation for clinical studies, supporting Study Teams and Functional Groups with TMF documents, SOPs, and record archiving. May serve as a resource during audits and inspections. _ Your Contributions: Perform data entry and reconciliation in clinical systems and tracking tools. Conduct secondary quality checks for TMF documents. Support study teams with documentation, tracking, and information retrieval. Organize on-site controlled clinical document storage. Assist with off-site archiving activities, including cataloguing and retrieval. Support TMF setup, review, maintenance, and archival in TMF Plans and Indexes. Ensure inspection readiness of documents and systems. Perform additional duties as assigned. Requirements: BS/BA in life sciences or related field, or RN with relevant clinical documentation experience, or a High School diploma with at least 4 years of clinical support experience. Understanding of clinical trial documentation, regulatory requirements, and TMF management (experience with Veeva preferred). Knowledge of clinical study processes and documents. Strong computer skills and familiarity with clinical systems. Excellent organizational, communication, problem-solving, and analytical skills. Attention to detail and ability to meet deadlines. Good project management skills. Ability to process, archive, and retrieve electronic documents.
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