Document and Clinical Systems Manager (TMF)
Neurocrine Biosciences
August 22, 2026
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
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 clinical information systems (CTMS, eTMF end-users) and facilitates responses to audits/inspections as TMF System Owner.
Your Contributions (include, but are not limited to)
- Support clinical system(s) functionality direction aligned with business demands and industry best practices
- Develop and present business cases for clinical system(s) implementation
- Provide compliance guidance for setup, maintenance, and reporting from clinical system(s)
- Plan/assist setup, review, maintenance, and archival of study-specific TMFs per regulations and industry standards
- Create TMF Plan and study-specific TMF Index documentation (including transitions/migrations)
- Serve as eTMF subject matter expert; provide technical advice and high-level service to end-users
- Lead monthly eTMF meetings; manage user access, training, and system releases
- Act as lead Clinical System Admin (organization setup, user help, troubleshooting)
- Generate monthly dashboards/reports; evaluate TMF accuracy, timeliness, completeness KPI performance
- Inform CO Study Team Leaders/Managers of deficiencies; support audits/inspections and inspector access
- Participate in quarterly TMF Veeva updates and Computer System Validation as necessary
- Support Change Incident Management and Risk Assessment; attend CO and eTMF QC meetings
- Create TMF SOPs and Work Instructions; maintain expertise in regulatory requirements (ICH/GCP, etc.)
- Build relationships with cross-functional groups (Regulatory, Biometrics, Safety Pharmacovigilance, Drug Supply, CROs, vendors)
Requirements
- BS/BA in life science (or related) or RN AND 6+ years clinical trial documentation experience (biotech/pharma or CRO); OR Master’s in life science AND 4+ years
- Knowledge of FDA regulations, GCPs, and ICH guidelines
- Working knowledge of clinical trial documents and TMF management in clinical systems (eTMF and CTMS; Veeva preferred)
- Ability to process/archive/retrieve electronic documents; working knowledge of clinical trials
- Excellent computer skills (MS Office), communication, problem-solving, analytical and project management skills
Benefits (if part of job description)
- Retirement savings plan (with match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision)
Application instructions
- Not provided in the text provided.
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 clinical information systems (CTMS, eTMF end-users) and facilitates responses to audits/inspections as TMF System Owner.
Your Contributions (include, but are not limited to)
- Support clinical system(s) functionality direction aligned with business demands and industry best practices
- Develop and present business cases for clinical system(s) implementation
- Provide compliance guidance for setup, maintenance, and reporting from clinical system(s)
- Plan/assist setup, review, maintenance, and archival of study-specific TMFs per regulations and industry standards
- Create TMF Plan and study-specific TMF Index documentation (including transitions/migrations)
- Serve as eTMF subject matter expert; provide technical advice and high-level service to end-users
- Lead monthly eTMF meetings; manage user access, training, and system releases
- Act as lead Clinical System Admin (organization setup, user help, troubleshooting)
- Generate monthly dashboards/reports; evaluate TMF accuracy, timeliness, completeness KPI performance
- Inform CO Study Team Leaders/Managers of deficiencies; support audits/inspections and inspector access
- Participate in quarterly TMF Veeva updates and Computer System Validation as necessary
- Support Change Incident Management and Risk Assessment; attend CO and eTMF QC meetings
- Create TMF SOPs and Work Instructions; maintain expertise in regulatory requirements (ICH/GCP, etc.)
- Build relationships with cross-functional groups (Regulatory, Biometrics, Safety Pharmacovigilance, Drug Supply, CROs, vendors)
Requirements
- BS/BA in life science (or related) or RN AND 6+ years clinical trial documentation experience (biotech/pharma or CRO); OR Master’s in life science AND 4+ years
- Knowledge of FDA regulations, GCPs, and ICH guidelines
- Working knowledge of clinical trial documents and TMF management in clinical systems (eTMF and CTMS; Veeva preferred)
- Ability to process/archive/retrieve electronic documents; working knowledge of clinical trials
- Excellent computer skills (MS Office), communication, problem-solving, analytical and project management skills
Benefits (if part of job description)
- Retirement savings plan (with match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical, prescription drug, dental, vision)
Application instructions
- Not provided in the text provided.