Principal, Database Programmer

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 Summary

We have already identified and interviewed the candidate that is provided via Hobson Prior agency

Job Description

ROLE

The Principal Database Programmer role involves the following characteristics:

• Lead and drive the DBP team, acting as mentor and coach 

• Contribute to develop the clinical database to collect the clinical data provided on paper or electronic CRFs 

• Program the computerized checks or SAS checks to ensure clean, accurate and complete clinical data can be delivered to customers 

• Act as the reference point for the Lead Data Manager and study Project Manager from the Database Programming perspective, ensuring DBP tasks for the assigned studies are performed on time and within budget 

• Make recommendation for process improvement and/or new standards development 

• Effective input into strategic planning across the department 

• Bridge scientific or medical knowledge into database programming processes to ensure sound data collection tools, validations and integration to fit for purpose clinical datasets 

KEY RESPONSABILITIES 

• Accountable for driving achievement of project milestones from study start up through to delivery of database and monitoring of time spent on tasks 

• Provide Database Programming input into the protocol data collection assessments 

• Create the annotated CRF (aCRF) using company standards or Sponsor’s naming conventions in accordance to relevant company procedures 

• Accountable for building of 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  

• Implement mid study changes to the production eCRF when requested by the Lead DM 

• Communicate the database setup status and the achievement of milestones to the Lead DM 

• Create and validate import programs of electronic data received from external vendors 

• Import electronic data received from external vendors during the course of the clinical study 

• 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) 

• Contribute in formal training for new database programming staff 

• 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 

• Lead the DBP team, coordinate other DBP staff providing direction regarding work assignment, scheduling and prioritizing; monitor progress of activities 

• Maintain continuous an