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Neurocrine Biosciences · 7 hours ago

Clinical Compliance Manager

San Diego, CA

Full-time

Onsite

Mid, Senior Level

$131K/yr - $179K/yr

4+ years exp

Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to developing life-changing treatments for patients. The Clinical Compliance Manager will lead strategic initiatives related to clinical process compliance and inspection readiness, while collaborating with various teams to enhance efficiency and effectiveness across clinical operations.

BiotechnologyHealth CarePharmaceutical

Comp. & Benefits

Responsibilities

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 Study-Specific Training (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

Qualification

Clinical ComplianceClinical Practices (GCP)Regulatory ComplianceVeeva VaultProject ManagementAnalytical ThinkingLeadership SkillsCommunication SkillsInterpersonal SkillsOrganizational Skills

Required

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

Comprehensive understanding 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

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