09 ott - Provincia di Monza e della Brianza
Alira Health
Overview
As Principal Database Programmer, you lead the Database Programming (DBP) team and shape the clinical database to capture study data from paper and electronic CRFs. You develop data checks (SAS and otherwise), ensuring accurate, complete data delivery to customers, while guiding project timelines and budget. You'll influence department strategy, drive process improvements, and align data collection with scientific and clinical needs. This is a collaborative, cross-functional role with a strong impact on data quality and study success.
Responsabilità
- Lead and coordinate the DBP team to meet project milestones from start-up to delivery
- Provide input on protocol data collection assessments
- Create annotated CRFs (aCRFs) and build clinical databases per standards
- Develop computerized and SAS checks per the Data Validation Plan
- Implement mid-study changes to production eCRFs
- Communicate status and milestones to Lead DM
- Create/validate data import programs from external vendors
- Program and validate data listings, tracking, and metrics reports
- Plan and prioritize own work and escalate as needed
- Contribute to training for DBP staff and apply SOPs/ICH/GCP guidance
- Represent Database Programming in internal/external meetings
- Lead process improvements and development of new standards
- Educate team on data collection tools
- Maintain communication across study team and escalate issues when needed
- Provide consultancy across groups on DBP best practices
- Develop and maintain a network of study team contacts
- Mentor and coach DBP staff
- Monitor progress and quality of outputs
- Demonstrate knowledge across all aspects of Database Programming
Requisiti fondamentali
- Expert knowledge of Merative Zelta build and/or Medidata Rave build, with study builder certification a plus
- Bachelor level degree in Computer Science or related field or at least 6 years of pharma DB programming experience
- Knowledge of Alira Health systems
- Strong knowledge
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