Associate Specialist, Document & Clinical Systems Join to apply for the Associate Specialist, Document & Clinical Systems role at Neurocrine Biosciences Associate Specialist, Document & Clinical Systems 1 week ago Be among the first 25 applicants Join to apply for the Associate Specialist, Document & Clinical Systems role at Neurocrine Biosciences Get AI-powered advice on this job and more exclusive features. *PLEASE NOTE: TMF/eTMF EXPERIENCE IS REQUIRED FOR THIS ROLE* 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. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, 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 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 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 an Electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS). Assists in the coordination of documentation associated with conducting clinical studies. Supports Clinical Operations (CO) Study Teams and Functional Groups with management of the TMF documents, SOPs and record archiving. The TMF Document & Clinical Systems Associate/Specialist may serve as a resource during internal or external audits and regulatory inspections of the TMF. Your Contributions Perform data entry and reconciliation in various clinical systems and tracking tools Perform secondary quality check (QC) for documents submitted to the TMF Provide support to study teams including maintenance of documentation, clinical tracking, and information retrieval Assist with the organization of the controlled clinical document storage on-site Assist with off-site archiving activities (including cataloguing process and document retrieval) Assist the Sr. Specialist with documenting the setup, review, maintenance, and archival of study-specific TMFs in TMF Plans and study-specific TMF Index. Plans may include TMF transition and/or migration activities Work with study teams to ensure “inspection readiness” at all times Perform additional tasks and duties as assigned Requirements Working knowledge of clinical study documents and managing Trial Master Files in Clinical Systems (eTMF and CTMS - Veeva preferred) BS/BA degree in life science or related field or RN with relevant experience working directly with clinical trial documentation at a biotech/pharmaceutical company or CRO OR High School diploma and minimum of 4 years of clinical support experience with regulatory documents Understanding of Neurocrine's business objectives and services Experience in specific functional discipline with a desire to acquire higher-level knowledge and skills Comfortable with tools and processes supporting the functional area Ability to work as part of a team Strong interpersonal, organizational, communication, problem-solving, and analytical skills Detail-oriented Ability to meet deadlines Proficiency in processing, archiving, and retrieving electronic documents Working knowledge of clinical trials Neurocrine Biosciences is an EEO/Disability/Vets employer and values diversity, belonging, and respect. We encourage candidates to apply even if their experience doesn't perfectly match the outlined requirements. The hourly rate is estimated between $34.66-$48.98, depending on various factors. The position offers an annual bonus (target 15%), participation in a long-term incentive program, and benefits including retirement plans, paid time off, parental leave, health coverage, and more. Seniority level Entry level Employment type Full-time Job function Administrative Referrals can increase your chances of interviewing at Neurocrine Biosciences. Set job alerts for related roles. #J-18808-Ljbffr Neurocrine Biosciences
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