09 set - Verona
Alira Health
Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.
The Principal Database Programmer role involves the following characteristics:
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
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
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; Maintain continuous and appropriate communication with Lead DM and/or study Project Manager and share critical and general issues
Make recommendations for database setup process improvements and development of new standards
Input into and monitor progress against study project plan and extend issues to resolution at 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. DESIRED QUALIFICATION & EXPERIENCE
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 English Education
Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy
Contract Type Hourly
Alira Health is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance. From development to medical care, we complement the expertise of our Pharma, Biotech, and MedTech clients with a full spectrum of services across their entire solutions lifecycle. With offices around the world, Alira Health provides a vibrant and creative environment with benefits that include professional development, global travel, flexible work programs and more. We welcome your passion and drive, talent and entrepreneurial spirit, sense of service and teamwork. This broad global perspective and cultural richness has a direct impact on providing innovative solutions for our clients that lead to higher standards of care and an improved patient experience.
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