Principal Specialist, Clinical Data Management
Neurocrine Biosciences
August 18, 2026
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 for both in-house and outsourced clinical trial data; evaluates, develops, and implements data management processes, procedures, and tools to ensure business requirements are met; collaborates with Medical, DSPV, Regulatory, QC, and other internal customers to ensure high quality data in support of regulatory submissions, safety reporting, and publications.
Your Contributions
- Leads, performs, and oversees data management activities for clinical studies and/or clinical programs
- Performs hands-on clinical data management tasks: reviewing protocols, designing eCRFs, coordinating UAT, documenting edit check specs, QC’ing external data transfers, data quality checks/discrepancy review, and ensuring database lock activities
- Develops policies, SOPs, processes, and documents for data management
- Provides technical expertise and training within Data Management and related teams
- Supports QA audit responses and ensures Corrective Action Forms (CAFs) are closed appropriately
- Recommends improvements to data management practices and technology solutions
- Assists with standardized documents (eCRFs, edit checks)
- Oversees screening/selection/validation/implementation of data management software purchases/upgrades
- Participates in selecting outsourcing vendors; reviews proposal scope; monitors budgets as appropriate
- Coordinates timelines (database lock, DSMB, data review) and monitors CRO data management performance
- Ensures quality control checks and audit procedures are followed
- Runs data review listings; queries; codes Medical History and AE data using MedDRA; codes Concomitant Medications using WHO Drug
- Collaborates with database programmers to ensure CDISC/SDTM standards
- Identifies risks and communicates issues/solutions
- Participates in data management-related NDA submissions, as appropriate
- Supports performance evaluations and development plans
Requirements
- BS/BA in computer science (or related) + 8+ years pharma industry experience (in-house/sponsor or CRO); OR MS + 6+ years; OR PhD + 4+ years
- 3+ years supervisory/lead experience
- Knowledge of data management best practices; ability to work on and lead multiple teams
- Excellent computer skills; strong communication, problem-solving, analytical, and project management skills
- Proficiency with Word, Excel, PowerPoint; thorough understanding of drug development
- Proficiency with Medidata Rave (required)
- Strong knowledge of Good Clinical Data Management Practices; CDISC/CDASH/SDTM; FDA/industry guidelines (required)
- Familiarity with Business Objects and SAS helpful; other programming languages a plus
Benefits/Compensation
- Annual base salary: $130,800.00–$179,000.00; annual bonus (target 30% of earned base); equity long-term incentive; retirement match; paid vacation/holidays/personal days; caregiver/parental and medical leave; health benefits.
Application
- Apply through the company’s job application process.
Leads, performs, and oversees data management activities for assigned clinical studies for both in-house and outsourced clinical trial data; evaluates, develops, and implements data management processes, procedures, and tools to ensure business requirements are met; collaborates with Medical, DSPV, Regulatory, QC, and other internal customers to ensure high quality data in support of regulatory submissions, safety reporting, and publications.
Your Contributions
- Leads, performs, and oversees data management activities for clinical studies and/or clinical programs
- Performs hands-on clinical data management tasks: reviewing protocols, designing eCRFs, coordinating UAT, documenting edit check specs, QC’ing external data transfers, data quality checks/discrepancy review, and ensuring database lock activities
- Develops policies, SOPs, processes, and documents for data management
- Provides technical expertise and training within Data Management and related teams
- Supports QA audit responses and ensures Corrective Action Forms (CAFs) are closed appropriately
- Recommends improvements to data management practices and technology solutions
- Assists with standardized documents (eCRFs, edit checks)
- Oversees screening/selection/validation/implementation of data management software purchases/upgrades
- Participates in selecting outsourcing vendors; reviews proposal scope; monitors budgets as appropriate
- Coordinates timelines (database lock, DSMB, data review) and monitors CRO data management performance
- Ensures quality control checks and audit procedures are followed
- Runs data review listings; queries; codes Medical History and AE data using MedDRA; codes Concomitant Medications using WHO Drug
- Collaborates with database programmers to ensure CDISC/SDTM standards
- Identifies risks and communicates issues/solutions
- Participates in data management-related NDA submissions, as appropriate
- Supports performance evaluations and development plans
Requirements
- BS/BA in computer science (or related) + 8+ years pharma industry experience (in-house/sponsor or CRO); OR MS + 6+ years; OR PhD + 4+ years
- 3+ years supervisory/lead experience
- Knowledge of data management best practices; ability to work on and lead multiple teams
- Excellent computer skills; strong communication, problem-solving, analytical, and project management skills
- Proficiency with Word, Excel, PowerPoint; thorough understanding of drug development
- Proficiency with Medidata Rave (required)
- Strong knowledge of Good Clinical Data Management Practices; CDISC/CDASH/SDTM; FDA/industry guidelines (required)
- Familiarity with Business Objects and SAS helpful; other programming languages a plus
Benefits/Compensation
- Annual base salary: $130,800.00–$179,000.00; annual bonus (target 30% of earned base); equity long-term incentive; retirement match; paid vacation/holidays/personal days; caregiver/parental and medical leave; health benefits.
Application
- Apply through the company’s job application process.