16 ott - Bardi
Alira Health
OverviewAs 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.
ResponsabilitàLead 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 fondamentaliExpert 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 of Data Management processes and pharma guidelines (ICH, GCP)
Expertise in SAS programming
Experience with clinical data management systems
Strong English proficiency
Proficient in MS Office Suite
Professional
Trustworthy
Team Player
SAS programming
Clinical data management systems (e.g., Medidata Rave)
Merative Zelta build
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