Document and Clinical Systems Manager (TMF)
Neurocrine Biosciences
19 days ago
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 quality, compliance, and inspection-readiness of all Neurocrine trial master files (TMF). Serves as subject matter expert for Clinical information systems, including CTMS and 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)
- Support strategic direction of clinical system functionality aligned to business demands and industry best practices
- Participate in business cases for clinical system implementation
- Provide compliance guidance for setup, maintenance, and reporting for one or more clinical systems
- Plan/assist setup, review, maintenance, and archival of study-specific TMFs per regulations/industry standards with CO teams and stakeholders
- Create TMF Plan and study-specific TMF Index documentation (incl. transition/migration activities)
- Serve as eTMF subject matter expert; provide technical advice and proactive end-user support
- Lead monthly eTMF meetings
- Manage clinical system: user access, training, and releases
- Act as lead Clinical System Admin (organization setup, user help, troubleshooting)
- Generate monthly dashboards/reports; evaluate TMF KPIs (accuracy, timeliness, completeness)
- Inform leaders of TMF deficiencies found via informal reviews
- Prepare for and participate in audits/inspections; provide responses and facilitate inspector access
- Participate in quarterly TMF Veeva updates and Computer System Validation as needed
- Support Change Incident Management and Risk Assessment; attend CO/eTMF QC meetings
- Create TMF SOPs and Work Instructions aligned with industry best practices
- Maintain working knowledge of regulatory requirements (electronic technology standards, ICH/GCP, SOPs)
- Collaborate with other functional areas (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 degree AND 4+ years
- Knowledge of best practices in TMF/clinical systems; familiarity with broader business concepts
- Leadership; ability to work as part of and lead multiple teams
- Excellent computer, communications, problem-solving, analytical, and project management skills
- Knowledge of FDA regulations, GCP, and ICH Guidelines
- Working knowledge of clinical study documents and managing TMFs in clinical systems (eTMF and CTMS; Veeva preferred)
- Ability to process/archive/retrieve electronic documents; working knowledge of clinical trials required
- Computer proficiency with MS Office
Compensation/Benefits (as stated)
- Base salary: $130,800.00–$179,000.00; annual bonus target 30%; eligibility for equity long-term incentive
- Retirement savings plan (company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and medical/prescription/dental/vision benefits
Provides strategic support to Clinical Operations (CO) Study Teams by creating plans for quality, compliance, and inspection-readiness of all Neurocrine trial master files (TMF). Serves as subject matter expert for Clinical information systems, including CTMS and 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)
- Support strategic direction of clinical system functionality aligned to business demands and industry best practices
- Participate in business cases for clinical system implementation
- Provide compliance guidance for setup, maintenance, and reporting for one or more clinical systems
- Plan/assist setup, review, maintenance, and archival of study-specific TMFs per regulations/industry standards with CO teams and stakeholders
- Create TMF Plan and study-specific TMF Index documentation (incl. transition/migration activities)
- Serve as eTMF subject matter expert; provide technical advice and proactive end-user support
- Lead monthly eTMF meetings
- Manage clinical system: user access, training, and releases
- Act as lead Clinical System Admin (organization setup, user help, troubleshooting)
- Generate monthly dashboards/reports; evaluate TMF KPIs (accuracy, timeliness, completeness)
- Inform leaders of TMF deficiencies found via informal reviews
- Prepare for and participate in audits/inspections; provide responses and facilitate inspector access
- Participate in quarterly TMF Veeva updates and Computer System Validation as needed
- Support Change Incident Management and Risk Assessment; attend CO/eTMF QC meetings
- Create TMF SOPs and Work Instructions aligned with industry best practices
- Maintain working knowledge of regulatory requirements (electronic technology standards, ICH/GCP, SOPs)
- Collaborate with other functional areas (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 degree AND 4+ years
- Knowledge of best practices in TMF/clinical systems; familiarity with broader business concepts
- Leadership; ability to work as part of and lead multiple teams
- Excellent computer, communications, problem-solving, analytical, and project management skills
- Knowledge of FDA regulations, GCP, and ICH Guidelines
- Working knowledge of clinical study documents and managing TMFs in clinical systems (eTMF and CTMS; Veeva preferred)
- Ability to process/archive/retrieve electronic documents; working knowledge of clinical trials required
- Computer proficiency with MS Office
Compensation/Benefits (as stated)
- Base salary: $130,800.00–$179,000.00; annual bonus target 30%; eligibility for equity long-term incentive
- Retirement savings plan (company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and medical/prescription/dental/vision benefits