Sr. Specialist, Document & Clinical Systems

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 #J-18808-Ljbffr Scorpion Therapeutics