Principal Specialist, Clinical Data Management
Neurocrine Biosciences
15 days 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.