Clinical Compliance Manager
Neurocrine Biosciences
August 18, 2026
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
About The Role
Independently leads and collaborates with Clinical Operations (ClinOps) to drive strategic initiatives related to clinical process compliance, continuous improvement, and inspection readiness. Shapes and implements process enhancements, including study-specific training programs and management of NBI consent document templates. Oversees training facilitation and creation/revision of controlled documents to ensure operational excellence. Acts as a key ClinOps liaison, identifying procedural gaps and championing solutions to improve clinical processes.
Your Contributions (include, But Are Not Limited To)
- Guides study teams on audit/inspection activities; escalates issues to Clinical Compliance (CC) Director when necessary
- Serves as ClinOps point person for clinical processes and Good Clinical Practices (GCP)
- Develops/reviews ClinOps controlled documents with SME input; assesses impact; proposes implementation plans; manages timelines
- Leads process integration and collaboration with vendors (e.g., CROs)
- Oversees management/updating of NBI consent document templates and related documents
- Collaborates with NBI Drug Safety and Pharmacovigilance (DSPV) to ensure risk language accuracy in consent documents
- Manages Study-Specific Training (SST) activities and SST system solution updates/user access
- Manages ClinOps training activities (materials and live training sessions under CC Director guidance)
- Oversees distribution list (DL) management process for safety reports
- Oversees ClinOps training curriculum reviews and controlled document assignment by role
- Participates in departmental/cross-department meetings; maintains relationships across functions
- Maintains knowledge of regulatory requirements and business standards
Requirements
- BS/BA in life science (or related) AND 6+ years in Clinical Compliance/Clinical Operations/related (CRA/CTM/Clinical Research Coordinator preferred) OR Master’s + 4+ years
- Proven expertise in audit/inspection activities, GCP, regulatory compliance, and inspection readiness
- Strong leadership, collaboration, and communication skills
- Extensive experience with controlled documents, training management, and cross-department coordination
- Excellent organizational/detail skills; ability to mentor junior team members
- Project management expertise (resource/timeline governance, risk mitigation)
- Computer skills (Veeva Vault preferred)
- Working knowledge of Clinical Operations (start-up through close-out)
- Advanced problem-solving/analytical skills; ability to meet multiple deadlines with accuracy
Benefits/Compensation (as stated)
- Base salary: $130,800.00–$179,000.00; annual bonus target 30% of earned base; equity long-term incentive eligibility; retirement match, paid vacation/holidays/personal days, caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision).
Independently leads and collaborates with Clinical Operations (ClinOps) to drive strategic initiatives related to clinical process compliance, continuous improvement, and inspection readiness. Shapes and implements process enhancements, including study-specific training programs and management of NBI consent document templates. Oversees training facilitation and creation/revision of controlled documents to ensure operational excellence. Acts as a key ClinOps liaison, identifying procedural gaps and championing solutions to improve clinical processes.
Your Contributions (include, But Are Not Limited To)
- Guides study teams on audit/inspection activities; escalates issues to Clinical Compliance (CC) Director when necessary
- Serves as ClinOps point person for clinical processes and Good Clinical Practices (GCP)
- Develops/reviews ClinOps controlled documents with SME input; assesses impact; proposes implementation plans; manages timelines
- Leads process integration and collaboration with vendors (e.g., CROs)
- Oversees management/updating of NBI consent document templates and related documents
- Collaborates with NBI Drug Safety and Pharmacovigilance (DSPV) to ensure risk language accuracy in consent documents
- Manages Study-Specific Training (SST) activities and SST system solution updates/user access
- Manages ClinOps training activities (materials and live training sessions under CC Director guidance)
- Oversees distribution list (DL) management process for safety reports
- Oversees ClinOps training curriculum reviews and controlled document assignment by role
- Participates in departmental/cross-department meetings; maintains relationships across functions
- Maintains knowledge of regulatory requirements and business standards
Requirements
- BS/BA in life science (or related) AND 6+ years in Clinical Compliance/Clinical Operations/related (CRA/CTM/Clinical Research Coordinator preferred) OR Master’s + 4+ years
- Proven expertise in audit/inspection activities, GCP, regulatory compliance, and inspection readiness
- Strong leadership, collaboration, and communication skills
- Extensive experience with controlled documents, training management, and cross-department coordination
- Excellent organizational/detail skills; ability to mentor junior team members
- Project management expertise (resource/timeline governance, risk mitigation)
- Computer skills (Veeva Vault preferred)
- Working knowledge of Clinical Operations (start-up through close-out)
- Advanced problem-solving/analytical skills; ability to meet multiple deadlines with accuracy
Benefits/Compensation (as stated)
- Base salary: $130,800.00–$179,000.00; annual bonus target 30% of earned base; equity long-term incentive eligibility; retirement match, paid vacation/holidays/personal days, caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision).