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 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