Lead and drive the DBP team, acting as mentor and coach
Contribute to develop the clinical database to collect clinical data provided on paper or electronic CRFs
Program computerized checks and SAS checks to ensure clean, accurate and complete clinical data
Act as reference for Lead Data Manager and Project Manager on Database Programming perspective
Create annotated CRF (aCRF) using company or sponsor naming conventions
Build clinical database: create variables, codelists, forms and visits per aCRF
Develop computerized checks and SAS checks according to Data Validation Plan
Implement mid-study changes to production eCRF and communicate database setup status
Create and validate import programs for electronic data from external vendors
Program and validate listings, tracking/metric reports and coding reports
Plan, prioritise own work; contribute to training and apply SOPs/ICH/GCP; recommend process improvements
Requirements
Degree (preferably in Computer Science) or at least 6 years of experience in database programming field or similar in a pharmaceutical environment or equivalent
Knowledge of Alira Health systems
Very Good Knowledge of Data Management processes
Very Good Knowledge of pharmaceutical industry guidelines like ICH, GCP etc
Very Good Expert in one or more clinical data management systems and recognized for expertise
Knowledge of SAS programming, Very Good
English, Good
MS Office Suite, Good
Proven ability to analyse data capture problems and deliver high quality solutions
Experience leading and mentoring database programming staff
Ability to apply SOPs and regulatory guidance to database programming activities
Benefits
Professional development
Global travel
Flexible work programs
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.