Principal Specialist, Clinical Data Management
Neurocrine Biosciences
9 hours ago
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
About the Role
Leads, performs, and oversees data management activities for assigned clinical studies (in-house and outsourced), evaluating and implementing data management processes, procedures, and tools to meet business requirements; collaborates with Biometrics and internal partners (Medical, DSPV, Regulatory, QC, etc.) to ensure high-quality data for regulatory submissions, safety reporting, and publications.
Your Contributions (include, but not limited to)
- Leads, performs, and oversees clinical data management for studies/programs.
- Hands-on DM tasks: review protocols, design eCRFs, coordinate UAT, document edit check specs, QC external data transfers, conduct data quality checks/discrepancy review, ensure database lock completion.
- Develop/lead data management SOPs, processes, and related documents; advocate DM internally.
- Provide technical expertise and training; assist with QA audit responses/CAFs closure.
- Research industry trends; recommend improvements and technology solutions.
- Standardize DM documents (eCRFs, edit checks); oversee DM software selection/validation/implementation.
- Participate in vendor selection and review outsourcing proposals/SOWs; monitor budgets.
- Coordinate DM timelines (database lock, DSMB, data review) and monitor CRO DM performance.
- Ensure QC/audit procedures per SOPs; run data listings, issue queries; code Med History & AEs (MedDRA) and Concomitant Meds (WHO Drug).
- Ensure CDISC/SDTM standards; identify risks and communicate issues/solutions.
- Support NDA submission activities as appropriate.
Knowledge & Qualifications
- Proficiency: Word, Excel, PowerPoint (required); Medidata Rave (required); Word/Excel/PowerPoint.
- Strong knowledge: GCDMP, CDISC/CDASH/SDTM, FDA/industry guidelines (required); drug development process.
Requirements
- BS/BA in CS (or related) + 8+ years pharma industry experience (in-house/sponsor or CRO), OR Master’s + 6+ years, OR PhD + 4+ years.
- 3+ years supervisory/lead experience.
- Hands-on clinical database programming skills: SAS, SQL, Medidata Rave Architect.
- Preferred: Business Objects, Rave Targeted SDV, Batch Uploader; C# (custom functions).
- Ability to communicate effectively (verbal/written).
Benefits
- Annual bonus (target 30% of earned base salary) and eligibility for equity-based long-term incentive program; retirement plan match; paid time off/holiday; paid caregiver/parental and medical leave; medical/prescription/dental/vision coverage.
Leads, performs, and oversees data management activities for assigned clinical studies (in-house and outsourced), evaluating and implementing data management processes, procedures, and tools to meet business requirements; collaborates with Biometrics and internal partners (Medical, DSPV, Regulatory, QC, etc.) to ensure high-quality data for regulatory submissions, safety reporting, and publications.
Your Contributions (include, but not limited to)
- Leads, performs, and oversees clinical data management for studies/programs.
- Hands-on DM tasks: review protocols, design eCRFs, coordinate UAT, document edit check specs, QC external data transfers, conduct data quality checks/discrepancy review, ensure database lock completion.
- Develop/lead data management SOPs, processes, and related documents; advocate DM internally.
- Provide technical expertise and training; assist with QA audit responses/CAFs closure.
- Research industry trends; recommend improvements and technology solutions.
- Standardize DM documents (eCRFs, edit checks); oversee DM software selection/validation/implementation.
- Participate in vendor selection and review outsourcing proposals/SOWs; monitor budgets.
- Coordinate DM timelines (database lock, DSMB, data review) and monitor CRO DM performance.
- Ensure QC/audit procedures per SOPs; run data listings, issue queries; code Med History & AEs (MedDRA) and Concomitant Meds (WHO Drug).
- Ensure CDISC/SDTM standards; identify risks and communicate issues/solutions.
- Support NDA submission activities as appropriate.
Knowledge & Qualifications
- Proficiency: Word, Excel, PowerPoint (required); Medidata Rave (required); Word/Excel/PowerPoint.
- Strong knowledge: GCDMP, CDISC/CDASH/SDTM, FDA/industry guidelines (required); drug development process.
Requirements
- BS/BA in CS (or related) + 8+ years pharma industry experience (in-house/sponsor or CRO), OR Master’s + 6+ years, OR PhD + 4+ years.
- 3+ years supervisory/lead experience.
- Hands-on clinical database programming skills: SAS, SQL, Medidata Rave Architect.
- Preferred: Business Objects, Rave Targeted SDV, Batch Uploader; C# (custom functions).
- Ability to communicate effectively (verbal/written).
Benefits
- Annual bonus (target 30% of earned base salary) and eligibility for equity-based long-term incentive program; retirement plan match; paid time off/holiday; paid caregiver/parental and medical leave; medical/prescription/dental/vision coverage.