Principal Database Programmer

Alira Health

Verona

On-site

EUR 55,000 - 75,000

Part time

14 days+

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Job summary

A leading pharmaceutical company is seeking a Principal Database Programmer to lead and mentor the database programming team, ensuring the development of high-quality clinical databases. The role requires substantial experience in database programming, a deep understanding of the pharmaceutical industry standards, and proficiency in clinical data management systems. Ideal candidates will have at least six years of experience and be skilled in SAS programming. This position offers a full-time role with a mid-senior level designation.

Qualifications

6+ years of experience in database programming in a pharmaceutical environment.
Knowledge of ICH, GCP, and Data Management processes.
Expertise in one or more clinical data management systems.

Responsibilities

Lead and mentor the database programming team to ensure high-quality clinical databases.
Program computerized checks to ensure accurate clinical data delivery.
Create and validate clinical databases and data collection tools.

Skills

Expert on Merative Zelta build

SAS programming

Analytical thinking

Effective verbal communication skills

Ability to problem solve

Education

Degree in Computer Science or similar

Bachelor of Science (BS): Biology

Bachelor of Science (BS): Life Sciences

Bachelor of Science (BS): Pharmacy

Job description

Principal Database Programmer role at Alira Health

Job Description Summary

The Principal Database Programmer will lead and mentor the database programming team, ensuring high‑quality clinical databases that adhere to industry standards and project requirements.

Role Characteristics

Lead and drive the DBP team, acting as mentor and coach
Contribute to developing 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 DatabaseहाँProgramming perspective, ensuring DBP tasks for the assigned studies are performed on time and within budget
Make recommendations for process improvement and/or new standards development
Provide effective input into strategic planning across the department
Bridge scientific generalized knowledge into database programming processes to ensure sound data collection tools, validations and integration to fit for purpose clinical datasets

Key Responsibilities

Accountable for driving achievement of project milestones from study start‑up through to delivery of database and monitoring 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 according to relevant company procedures
Accountable for building the clinical database, creating variables, codelists, forms and visits in accordance with the aCRF
Develop 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 reports, etc.)
Program and validate tracking or metric reports
Plan and prioritise own work and take appropriate actions (e.g., escalation)
Contribute to 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 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 analyze 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

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 six years of experience in database programming field or similar in a pharmaceutical environment or equivalent
Knowledge of Alira Health systems stresifying 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

Technical Competencies & Soft Skills