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Job Description
Who We Are:
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, 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 more than 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, Facebook and YouTube. (•in collaboration with AbbVie) About the
Role:
Provides strategic support to Clinical Operations (CO) Study Teams by creating plans for the quality, compliance and inspection-readiness of all Neurocrine trial master files (TMF). The role serves as subject matter expert for electronic TMF (eTMF) end-users, and facilitates responses to audits/inspections. Collaborates closely with the Clinical Operations Study Team Members and Functional Groups as TMF System Owner. _ Your Contributions (include, but are not limited to): In collaboration with the CO Study Team, Vendors, Functional Group Representatives and other Stakeholders, plan/assist the set-up, review, maintenance and archival of study specific TMFs according to applicable regulations and industry standards Fully documents 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 Serves as subject matter expert for the eTMF, providing technical expertise and advice to end-users and all stakeholders. Takes a proactive role in providing a high level of service to eTMF end-users Lead monthly eTMF meetings for internal CO Study Team Administering Clinical System, including managing user access, user training, and system releases Act as Clinical System Admin (add organization, user help, troubleshoot errors, etc.) Generate and send out monthly dashboards and reports Provides informal review of key performance indicators related to clinical trial accuracy, timeliness and completeness of TMFs against milestone-based projections Proactively informs CO Study Team Leaders and Upper Managers of deficiencies from informal reviews Prepares for and participates in internal or external audits/inspections including providing audit/inspection responses and facilitating inspector access to TMFs, as required Participates in quarterly TMF Veeva update meetings and Computer System Validation activities, as necessary Supports CO Study Team Members in Change Incident Management and Risk Assessment as requested Participates in CO Study Team meetings and eTMF QC meetings, as requested Writes/edits TMF Standard Operating Procedures and Work Instructions to keep current with industry best practices for TMF management, quality and archival Demonstrates technical and strategic knowledge of applicable regulatory requirements, including electronic technology industry standards, applicable specifications, standard operating procedures, ICH/GCP guidelines and other regulatory requirements. Constantly maintains knowledge in an on-going manner Develops and maintains close working relationships with other functional areas outside of Clinical Operations e.g. Regulatory, Biometrics, Safety Pharmacovigilance, Drug Supply, CROs, Vendors etc. to facilitate TMF development Perform other duties as necessary and assigned by management
