Senior Database Programmer

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Job Description Summary

Job Description

ROLE

The Senior Database Programmer role includes:

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

• 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 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 

• 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 achieving project milestones from study start up through to delivery of database and monitoring of time spent on tasks 

• 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  

• 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 prioritize 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 and appropriate communication with Lead DM and share critical and general issues 

• Develop and maintain a network of contacts within the study team 

• Make recommendations for database setup process improvem