Specialist, Document & Clinical Systems (TMF)
Neurocrine Biosciences
19 days ago
Remote friendly (San Diego, CA)
United States
Operations
About the Role
Provides support to Clinical Operations (CO) Study Teams by creating plans for the quality, compliance, and inspection-readiness of all Neurocrine trial master files (TMFs). May serve 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
- Assist with set-up, review, maintenance, and archival of study-specific TMFs with CO Study Team, vendors, functional groups, and stakeholders per regulations and industry standards.
- Document TMF set-up, review, maintenance, and archival in TMF Plans and study-specific TMF Index (may include TMF transition/migration).
- Provide eTMF guidance and technical expertise/advice to end-users and stakeholders.
- Review key performance indicators for clinical trial accuracy, timeliness, and completeness of TMFs.
- Inform CO Study Team Leaders/Upper Managers of deficiencies.
- Prepare for and participate in internal/external audits/inspections; provide responses and facilitate inspector access to TMFs.
- Participate in quarterly TMF Veeva update meetings and Computer System Validation as needed.
- Support Change Incident Management and Risk Assessment as requested.
- Participate in CO Study Team and eTMF QC meetings as requested.
- Review and contribute to TMF SOPs and work instructions.
- Collaborate with other functions (e.g., Regulatory, Biometrics, Safety Pharmacovigilance, Drug Supply, CROs, vendors) to facilitate TMF development.
Requirements
- BS/BA in life science (or related) or RN AND 2+ years working with clinical trial documentation at a biotech/pharmaceutical company or CRO; OR Master’s in life science (or related) with relevant experience.
- Knowledge of FDA regulations, GCP/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, and retrieve documents electronically.
- Working knowledge of clinical trials.
- Strong computer skills (MS Office), detail-oriented, strong interpersonal/organizational/communication/problem-solving/analytical skills.
- Ability to work independently and as a team player; manage/prioritize own work; meet deadlines.
Benefits/Compensation (if applicable in posting)
- Annual base salary: $89,800.00–$123,000.00; annual bonus target 20% of base; eligibility for equity-based long-term incentive.
- Retirement plan with company match; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/dental/vision coverage.
Provides support to Clinical Operations (CO) Study Teams by creating plans for the quality, compliance, and inspection-readiness of all Neurocrine trial master files (TMFs). May serve 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
- Assist with set-up, review, maintenance, and archival of study-specific TMFs with CO Study Team, vendors, functional groups, and stakeholders per regulations and industry standards.
- Document TMF set-up, review, maintenance, and archival in TMF Plans and study-specific TMF Index (may include TMF transition/migration).
- Provide eTMF guidance and technical expertise/advice to end-users and stakeholders.
- Review key performance indicators for clinical trial accuracy, timeliness, and completeness of TMFs.
- Inform CO Study Team Leaders/Upper Managers of deficiencies.
- Prepare for and participate in internal/external audits/inspections; provide responses and facilitate inspector access to TMFs.
- Participate in quarterly TMF Veeva update meetings and Computer System Validation as needed.
- Support Change Incident Management and Risk Assessment as requested.
- Participate in CO Study Team and eTMF QC meetings as requested.
- Review and contribute to TMF SOPs and work instructions.
- Collaborate with other functions (e.g., Regulatory, Biometrics, Safety Pharmacovigilance, Drug Supply, CROs, vendors) to facilitate TMF development.
Requirements
- BS/BA in life science (or related) or RN AND 2+ years working with clinical trial documentation at a biotech/pharmaceutical company or CRO; OR Master’s in life science (or related) with relevant experience.
- Knowledge of FDA regulations, GCP/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, and retrieve documents electronically.
- Working knowledge of clinical trials.
- Strong computer skills (MS Office), detail-oriented, strong interpersonal/organizational/communication/problem-solving/analytical skills.
- Ability to work independently and as a team player; manage/prioritize own work; meet deadlines.
Benefits/Compensation (if applicable in posting)
- Annual base salary: $89,800.00–$123,000.00; annual bonus target 20% of base; eligibility for equity-based long-term incentive.
- Retirement plan with company match; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/dental/vision coverage.