Clinical Compliance Manager

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.

Neurocrine Biosciencesis 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, visitneurocrine.com, and follow the company onLinkedIn,XandFacebook. (*in collaboration with AbbVie)

About the Role:

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• Guides study teams on audit/inspection activities, offering insights on findings, and escalating issues to Clinical Compliance (CC) Director when necessary

• Serves as the ClinOps point person, providing key advice on clinical processes and Good Clinical Practices (GCP)

• Develops and reviews new or updated ClinOps controlled documents, coordinate input from Subject Matter Experts (SMEs), assess impact, propose implementation plans, and manage timelines

• Leads process integration and collaboration with vendors (e.g., CROs)

• Oversees the management and updating of NBI consent document templates and related documents

• Collaborates with NBI Drug Safety and Pharmacovigilance (DSPV) to ensure compound risk language is accurately included in consent documents

• Manages and oversees SST activities, such as maintenance SST matrix templates, processing of document submissions for SST assignments, and compliance with SST processes

• Manages SST system solution implementation, updates and user access

• Manages ClinOps training activities, including developing training materials and conducting live training sessions under guidance from CC Director

• Oversees the distribution lists (DL) management process (e.g., ensure DLs for internal distribution of safety reports are created and all applicable study team members are listed prior to the first study participant is screened)

• Oversees ClinOps training curriculum reviews, making sure controlled documents are assigned appropriately for training based on roles and consulting with group leads when necessary

• Participates and promotes collaboration in departmental and cross-departmental meetings, as necessary

• Develops and maintains working relationships with other functional areas outside of Clinical Operations

• Demonstrates knowledge of applicable regulatory requirements, and business standards

• Constantly maintains knowledge in an on-going manner

• Performs other duties as assigned

• BS/BA degree in life science or related field and 6+ years of experience in Clinical Compliance, Clinical Operations, or related areas within the biopharmaceutical industry. Previous experience as a Clinical Trial Associate (CRA), Clinical Trial Manager (CTM) or Clinical Research Coordinator, or equivalent, preferred. OR

• Master's degree life science or related field and 4+ years of similar experience noted above

• Proven expertise in audit/inspection-related activities, Good Clinical Practices (GCP), and regulatory compliance, and inspection readiness

• Strong leadership and collaboration skills, with a track record of effectively leading and supporting cross-functional teams

• Excellent communication and interpersonal skills, with the ability to work effectively with internal and external stakeholders

• Extensive experience in maintaining controlled documents, managing training activities, and coordinating cross-departmental collaboration

• Comprehensiveunderstanding of regulatory requirements and standards in the biopharmaceutical industry, with a commitment to ongoing learning and professional development

• Excellent organizational skills and be detail oriented

• Proficiency in both collaborative and independent work, with the capability to mentor and lead junior team members

• Comprehensive project management expertise, including resource allocation, timeline governance, and risk mitigation strategies

• Excellent computer skills. Experience with Veeva Vault preferred

• Working knowledge of Clinical Operations, specifically conducting clinical studies from start-up through close-out

• Advanced problem-solving and analytical thinking skills

• Ability to meet multiple deadlines, with a high degree of accuracy and efficiency

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Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.

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