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Job Description Summary
Job Description
ROLEThe 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 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
Expert on Merative Zelta build and/or Medidata Rave build, certification of study builder will be an added value
Degree (preferably in Computer Science) or at least 6 years of experience in database programming field or similar in a pharmaceutical environment or equivalent
Knowledge of Alira Health systems, Very Good
Knowledge of Data Management processes, Very Good
Knowledge of pharmaceutical industry guidelines like ICH, GCP etc, Very Good
Expert in one or more clinical data management systems and recognized for expertise
Knowledge of SAS programming, Very Good
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
Languages
EnglishEducation
Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): PharmacyContract Type
HourlySkills Required
- Expertise in Merative Zelta and/or Medidata Rave build
- Certification as study builder (Merative or Medidata)
- Bachelor's degree (preferably Computer Science) or at least 6 years database programming experience in a pharmaceutical environment
- Strong knowledge of Alira Health systems
- Very good knowledge of Data Management processes
- Very good knowledge of pharmaceutical industry guidelines (ICH, GCP)
- Expertise in one or more clinical data management systems
- Very good knowledge of SAS programming
- Proficiency in MS Office (Excel, Word, PowerPoint) and English communication skills
