Associate Specialist, Document & Clinical Systems

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. Assist 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 be responsible for serve as a resource during internal or external audits and regulatory inspections of the TMF.

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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

• Provides support to study team including, but not limited to, maintenance of documentation, clinical tracking and information retrieval.

• Assist with the organization of the controlled clinical document storage on-site

• Assists with off-site archiving activities (including cataloguing process and document retrieval).

• Assist the Sr. Specialist with documenting the set-up, 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 team to ensure “inspection readiness” at all times

• Perform additional tasks and duties as assigned

Requirements:

• BS/BA degree in life science or related field or RN    and    with some relevant experience working directly with clinical trial documentation working at a biotech/pharmaceutical company or CRO OR

• High School diploma and Minimum of 4 years of clinical support experience with essential regulatory documents

• Understands Neurocrine's business objectives and develops understanding of Neurocrine's services and customers

• Has expe