Clinical Compliance Specialist, Clinical Operations

About the Role Supports Clinical Operations (ClinOps) on efforts related to clinical process compliance, continuous improvement, and inspection readiness activities. Acts as a key contributor to various process-related tasks such as study-specific training processes and NBI consent document template management. Facilitates training and controlled document revisions and serves as ClinOps liaison to help identify and support resolution of procedural gaps and improve ways of working. Key Contributions Supports study teams on audit/inspection-related activities by providing guidance on findings and escalating to Clinical Compliance (CC) Sr. Specialist(s), Managers and Directors as needed. Acts as ClinOps liaison by providing guidance on clinical processes and Good Clinical Practices (GCP). Supports creation and revision of ClinOps controlled documents by generating initial drafts, consolidating comments, and scheduling meetings with Subject Matter Experts (SMEs). Maintains NBI consent document templates and associated documentation. Supports study teams on SST activities, including maintenance of SST matrix templates and processing document submissions for SST assignment under guidance of Sr. CC Specialist, Manager(s) and Director(s). Assists ClinOps training activities under direction of CC Sr. Specialist(s), Manager(s) and Director(s) (e.g., scheduling live training sessions, managing training records, drafting and distributing training materials). Manages the CC mailbox, redirecting inquiries to CC Sr. Specialist(s), Manager(s) and Director(s) as needed. Manages applicable distribution lists, e.g., internal distribution of safety reports from NBI Drug Safety and Pharmacovigilance to study teams. Supports ClinOps training curricula review (e.g., retrieving reports for current assignments, obtaining current job descriptions, scheduling meetings with group leads). Participates and promotes collaboration in departmental and cross‑departmental meetings as necessary. Provides administrative support, including maintenance of CC tools, authoring meeting minutes, and creating reports. Develops and maintains working relationships with other functional areas outside of Clinical Operations. Demonstrates knowledge of applicable regulatory requirements and business standards, continually maintaining knowledge in an on-going manner. Performs other duties as assigned. Requirements BS/BA degree in life science or related field AND2+years of experience in Clinical Compliance, Clinical Operations, or related areas within the biopharmaceutical industry. Previous experience as a Clinical Trial Specialist or Clinical Research Coordinator, or equivalent (preferred). OR Master’s degree in life science or related field AND some experience as noted above. Demonstrated understanding of Good Clinical Practices (GCP), regulatory compliance and inspection readiness. Strong organizational and communication skills, with the ability to work effectively in a team environment and collaborate with internal and external stakeholders. Proficiency in maintaining controlled documents, managing training activities, and maintaining distribution lists. Commitment to staying updated on regulatory requirements and standards in the biopharmaceutical industry. Ability to work as part of a team and independently. Good project management skills. Excellent computer skills; experience with Veeva Vault preferred. Working knowledge of clinical operations and conducting clinical studies from start‑up through close‑out. Ability to meet multiple deadlines with a high degree of accuracy and efficiency. Excellent interpersonal, verbal and written communication skills. Benefits Annual base salary: $81,000.00–$111,000.00 depending on location, role complexity, and experience. Eligible for an annual bonus with a target of 20% of the earned base salary and participation in an equity‑based long‑term incentive program. Retirement savings plan with company match, paid vacation, holiday, and personal days, paid caregiver/parental and medical leave. Comprehensive health benefits including medical, prescription drug, dental, and vision coverage per applicable plans. Equal Opportunity Employer Neurocrine Biosciences is an EEO/Disability/Vets employer. #J-18808-Ljbffr Neurocrine Biosciences