IndirizzoDescrizione del lavoro:
Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.
Job Description
ROLE
The Database Programmer contributes to develop the clinical database to collect the clinical data provided on paper or electronic CRFs, program the computerized checks or SAS checks and ensures clean, accurate and complete clinical data can be delivered to customers at the highest quality in accordance with the project plan and study timelines.
KEY RESPONSABILITIES
* Create the annotated CRF (aCRF) using company standards or sponsor's naming conventions in accordance to relevant company procedures
* Build the clinical database, creating variables, codelists, forms and visits in accordance with the aCRF
* Develop the computerized checks in accordance with the Data Validation Plan
* Develop SAS checks in accordance with the Data Validation Plan
* Validate the database structure and the computerized checks or SAS checks
* Implement mid study changes to the production eCRF
* Create and validate import programs of electronic data received from external vendors
* Import electronic data received from external vendors
* Program and validate data listings (e.g. Manual checks, Medical Review listings, Coding report etc)
* Program and validate tracking or metric reports
* Plan and prioritise his/her own work and take appropriate actions (e.g., escalation)
* Apply SOPs and guidance documents as well as applicable industry standards like ICH, GCP etc to day-to-day activities generating all the required documentation for study files
* Monitor progress of activities and communicate the status of activities and the achievement of milestones to the Lead DM
* Maintain continuous and appropriate communication with Lead DM and share critical and general issues
* Conduct other activities as required
DESIRED QUALIFICATION & EXPERIENCE
* Degree (preferably in Computer Science) or at least 1 year of experience in database programming or similar field in a pharmaceutical environment or equivalent
* Knowledge of (COMPANY NAME) systems, Fair
* Basic understanding of pharmaceutical industry guidelines like ICH, GCP etc
* Basic understanding of Data Management processes
TECHNICAL COMPETENCES & SOFT SKILLS
* Knowledge of SAS programming, Fair
* English, Fair
* MS Office Suite, Good
* Professional
* Trustworthy
* Ability to effectively prioritize
* Quality focused
* Personable Attitude
* Willingness to learn
* Team Player
Contract TypeIntern (Fixed Term) (Trainee)
