Principal Specialist, Clinical Data Management
Neurocrine Biosciences
5 hours ago
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
Principal Analyst, Clinical Data Management
Your Contributions (include, but are not limited to):
- Train, supervise, evaluate, and mentor/develop clinical database programmers to support creation and maintenance of clinical study databases
- Develop and monitor database-related timelines (database setup, validation procedure programming, and batch data transfer timing)
- Evaluate current processes; set standards and ensure consistency across programs and studies
- Set priorities and ensure alignment with company objectives
- Oversee quality of work to meet company-defined standards
- Oversee electronic data loading (vendor specifications, timeline monitoring, data loading); update/install coding dictionary versions; participate in installation/validation/implementation of new software
- Develop SOPs, work instructions, and Data Management Plan documents; ensure processes are followed and work is documented per SOPs
- Ensure process efficiency; identify gaps and implement alternative processes as needed
- Analyze high-complexity problems; develop/implement alternative solutions internally and with vendors; identify inconsistencies and process improvement opportunities
- Serve as expert resource for clinical database programming; liaison between Clinical Data Management and project teams
- Perform clinical database programming tasks (programs/reports for data review/cleaning; build Medidata Rave EDC databases; validation/derivation procedures; audit listings; database migrations; Targeted SDV configuration; create SAS datasets; maintain Global Library)
- Manage contractors/consultants and CRO (if appropriate)
- Research and recommend new technology to streamline data collection, validation, and review
Requirements:
- BS/BA in computer science (or related) AND 8+ years pharmaceutical industry experience (in-house/sponsor or CRO)
- OR Master’s degree (computer science or related) AND 6+ years relevant experience
- OR PhD (computer science or related) AND 4+ years relevant experience
- OR 3+ years supervisory/lead experience
- Knowledge of best practices in the functional discipline and related business concepts
- Ability to work as part of and lead multiple teams; leadership skills to lead lower levels/indirect teams
- Excellent computer skills, communication, problem-solving, analytical thinking
- Understanding of drug development process
- Experience with GCP and CDISC/CDASH/SDTM standards
- Experience developing SOPs/Work Instructions and following FDA guidance
- Hands-on clinical database programming skills: SAS, SQL, Medidata Rave Architect
Preferred:
- Experience with Business Objects, Rave Targeted SDV, and Batch Uploader
- Experience with C# programming (custom functions)
Benefits (if explicitly stated):
- Annual base salary: $130,800.00–$179,000.00
- Annual bonus (target 30% of earned base salary) and eligibility for equity long-term incentive program
- Retirement savings plan (company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical/prescription drug/dental/vision)
Your Contributions (include, but are not limited to):
- Train, supervise, evaluate, and mentor/develop clinical database programmers to support creation and maintenance of clinical study databases
- Develop and monitor database-related timelines (database setup, validation procedure programming, and batch data transfer timing)
- Evaluate current processes; set standards and ensure consistency across programs and studies
- Set priorities and ensure alignment with company objectives
- Oversee quality of work to meet company-defined standards
- Oversee electronic data loading (vendor specifications, timeline monitoring, data loading); update/install coding dictionary versions; participate in installation/validation/implementation of new software
- Develop SOPs, work instructions, and Data Management Plan documents; ensure processes are followed and work is documented per SOPs
- Ensure process efficiency; identify gaps and implement alternative processes as needed
- Analyze high-complexity problems; develop/implement alternative solutions internally and with vendors; identify inconsistencies and process improvement opportunities
- Serve as expert resource for clinical database programming; liaison between Clinical Data Management and project teams
- Perform clinical database programming tasks (programs/reports for data review/cleaning; build Medidata Rave EDC databases; validation/derivation procedures; audit listings; database migrations; Targeted SDV configuration; create SAS datasets; maintain Global Library)
- Manage contractors/consultants and CRO (if appropriate)
- Research and recommend new technology to streamline data collection, validation, and review
Requirements:
- BS/BA in computer science (or related) AND 8+ years pharmaceutical industry experience (in-house/sponsor or CRO)
- OR Master’s degree (computer science or related) AND 6+ years relevant experience
- OR PhD (computer science or related) AND 4+ years relevant experience
- OR 3+ years supervisory/lead experience
- Knowledge of best practices in the functional discipline and related business concepts
- Ability to work as part of and lead multiple teams; leadership skills to lead lower levels/indirect teams
- Excellent computer skills, communication, problem-solving, analytical thinking
- Understanding of drug development process
- Experience with GCP and CDISC/CDASH/SDTM standards
- Experience developing SOPs/Work Instructions and following FDA guidance
- Hands-on clinical database programming skills: SAS, SQL, Medidata Rave Architect
Preferred:
- Experience with Business Objects, Rave Targeted SDV, and Batch Uploader
- Experience with C# programming (custom functions)
Benefits (if explicitly stated):
- Annual base salary: $130,800.00–$179,000.00
- Annual bonus (target 30% of earned base salary) and eligibility for equity long-term incentive program
- Retirement savings plan (company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical/prescription drug/dental/vision)