Sr. Specialist, Document & Clinical Systems
Neurocrine Biosciences
June 27, 2026
Remote friendly (San Diego, CA)
United States
IT
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). Serves as subject matter expert for electronic TMF (eTMF) end-users and facilitates responses to audits/inspections. Collaborates with CO Study Team Members and Functional Groups as TMF System Owner.
Your Contributions (include, but are not limited to)
- Plan/assist the set-up, review, maintenance, and archival of study-specific TMFs with CO Study Team, vendors, functional representatives, and stakeholders
- Document TMF setup/review/maintenance/archival in TMF Plans and study-specific TMF Index (may include TMF transition/migration)
- Serve as eTMF subject matter expert; provide technical advice to end-users
- Lead monthly eTMF meetings for the internal CO Study Team
- Administer the clinical system (user access, training, releases); act as Clinical System Admin
- Generate and send monthly dashboards/reports
- Review KPIs for TMF accuracy, timeliness, and completeness; inform leaders/managers of deficiencies
- Prepare for and support internal/external audits/inspections (responses and inspector access)
- Participate in quarterly TMF Veeva update meetings and Computer System Validation as needed
- Support Change Incident Management and Risk Assessment as requested
- Write/edit TMF SOPs and Work Instructions
- Maintain regulatory and eTMF knowledge (FDA, GCP/ICH, standards, SOPs)
- Partner with other functions (Regulatory, Biometrics, Safety Pharmacovigilance, Drug Supply, CROs, vendors)
Requirements
- BS/BA in life science (or related) or RN AND 4+ years with clinical trial documentation at a biotech/pharma or CRO; or MS AND 2+ years
- Ability to work independently and as a team player; manage/prioritize work
- Knowledge of FDA regulations, GCP, and ICH guidelines
- Working knowledge of clinical study documents and managing Trial Master Files in clinical systems (eTMF and CTMS; Veeva preferred)
- Ability to process/archive/retrieve electronic documents
- Working knowledge of clinical trials
- Proficiency with MS Office
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). Serves as subject matter expert for electronic TMF (eTMF) end-users and facilitates responses to audits/inspections. Collaborates with CO Study Team Members and Functional Groups as TMF System Owner.
Your Contributions (include, but are not limited to)
- Plan/assist the set-up, review, maintenance, and archival of study-specific TMFs with CO Study Team, vendors, functional representatives, and stakeholders
- Document TMF setup/review/maintenance/archival in TMF Plans and study-specific TMF Index (may include TMF transition/migration)
- Serve as eTMF subject matter expert; provide technical advice to end-users
- Lead monthly eTMF meetings for the internal CO Study Team
- Administer the clinical system (user access, training, releases); act as Clinical System Admin
- Generate and send monthly dashboards/reports
- Review KPIs for TMF accuracy, timeliness, and completeness; inform leaders/managers of deficiencies
- Prepare for and support internal/external audits/inspections (responses and inspector access)
- Participate in quarterly TMF Veeva update meetings and Computer System Validation as needed
- Support Change Incident Management and Risk Assessment as requested
- Write/edit TMF SOPs and Work Instructions
- Maintain regulatory and eTMF knowledge (FDA, GCP/ICH, standards, SOPs)
- Partner with other functions (Regulatory, Biometrics, Safety Pharmacovigilance, Drug Supply, CROs, vendors)
Requirements
- BS/BA in life science (or related) or RN AND 4+ years with clinical trial documentation at a biotech/pharma or CRO; or MS AND 2+ years
- Ability to work independently and as a team player; manage/prioritize work
- Knowledge of FDA regulations, GCP, and ICH guidelines
- Working knowledge of clinical study documents and managing Trial Master Files in clinical systems (eTMF and CTMS; Veeva preferred)
- Ability to process/archive/retrieve electronic documents
- Working knowledge of clinical trials
- Proficiency with MS Office