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 and appropriate communication with Lead DM and/or study Project Manager and share critical and general issues
Develop and maintain a network of contacts within the study team
Make recommendations for database setup process improvements and development of new standards
Input into and monitor progress against study project plan and escalate issues to resolution at the appropriate level
Proven ability to analyse data capture problems/opportunities and a track record of developing and delivering high quality solutions
Demonstrate broad and integrated knowledge of all aspects of Database Programming providing consultancy to other groups outside DBP
Educate/train on use of study specific data collection tool(s)
Make recommendations for process improvements and development of new standards
Effectively represents Database Programming in internal or external meetings (e.g. EDC demos)
Conduct other activities as required
