Principal Database Programmer

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

English, Good 

MS Office Suite, Good

Professional  

Trustworthy 

Ability to effectively prioritize

Quality focused 

Personable Attitude 

Willingness to learn 

Team Player 

Effective Stress Management Techniques 

Learning Agility 

Ability to Manage Conflict  

Problem Solving Skills 

Effective Verbal Communication Skills 

Commercial and Technical Writing Skills 

Networking Skills 

Analytical thinking 

Resilient 

Ability to Influence and motivate 

Ability to manage difficult conversations 

Innovative 

Ability to Provide Constructive Feedback 

Excellent Presentation Skills 

Commercial awareness 

Ability to recognize and develop talent