Clinical Database Programmer I

Kelly Science, Engineering, Technology & Telecom; Colombia; Presencial; COP 66.960.000 - 111.600.000; Jornada completa

Descripción de la vacante

Kelly Science, Engineering, Technology & Telecom is seeking a Clinical Database Programmer I to configure clinical study databases, build edit checks, and ensure data quality throughout the trial lifecycle.

You will work with Data Management, Clinical Operations, study teams, and external partners to translate study requirements into compliant data capture solutions and reliable reporting.

Formación

• Bachelor’s degree in a relevant field.
• At least 1 year of clinical database programming/EDC configuration experience.
• Experience with an EDC platform; Medidata Rave preferred.
• Understanding of clinical trial data, CRF/eCRF design, and data validation.
• Familiarity with CDISC CDASH, ICH GCP, and 21 CFR Part 11.
• Strong attention to detail and data quality.
• Ability to interpret specifications and configure system functionality.
• Strong written and verbal communication, and teamwork.

Responsabilidades

• Configure study databases on an EDC platform such as Medidata Rave.
• Build/edit checks, calculations, and dynamic forms; test and validate.
• Create and maintain study forms, fields, and dictionaries.
• Perform database testing, validation, and UAT.
• Document results, defects, and database releases.
• Support external data feeds mapping and reconciliation.
• Implement database changes, migrations, and amendments.
• Generate reports/listings for data review.
• Maintain audit trails, version control, and configuration docs.
• Track deliverables, risks, and issues affecting timelines.
• Support data mapping, system integration, and audits as needed.

Conocimientos

EDC configuration

Clinical data management

CDASH principles

Attention to detail

data validation

Documentation

Team collaboration

Educación

Bachelor's degree in computer science, life sciences, health sciences, mathematics, statistics

Herramientas

Medidata Rave

Descripción del empleo

About the Role

We are seeking a Clinical Database Programmer I to support the configuration, testing, and maintenance of clinical study databases. In this role, you will help translate approved study requirements into reliable electronic data capture solutions that support high-quality clinical data and compliant study delivery.

You will work closely with Data Management, Clinical Operations, study teams, and external partners throughout the clinical trial lifecycle.

What You'll Do

• Configure clinical study databases using an EDC platform such as Medidata Rave.
• Build and test edit checks, calculations, derivations, conditional logic, and dynamic forms.
• Create and maintain study forms, fields, folders, matrices, dictionaries, and related database components.
• Perform database testing, validation, and user acceptance testing.
• Document test results, defects, resolutions, and database releases.
• Support the setup and reconciliation of external data feeds, including laboratory, ECG, imaging, and ePRO data.
• Implement approved database changes, amendments, and migration activities.
• Build and test reports and listings used for clinical data review.
• Maintain configuration, version-control, and audit-readiness documentation.
• Work with project teams to track deliverables, identify risks, and elevate issues affecting timelines or data integrity.
• Support data mapping, system integration, and audit activities as required.

Must-Have Skills and Experience

• Bachelor's degree in computer science, life sciences, health sciences, mathematics, statistics, or a related field.
• At least 1 year of experience in clinical database programming, EDC configuration, clinical data management systems, or a related area.
• Experience using an EDC or clinical database platform; Medidata Rave experience is preferred.
• Understanding of clinical trial data, CRF/eCRF design, database testing, and data validation.
• Familiarity with CDISC CDASH principles.
• Working knowledge of ICH GCP and computerized system compliance requirements, including 21 CFR Part 11.
• Strong attention to detail and commitment to data quality.
• Ability to interpret specifications and accurately configure system functionality.
• Strong organizational, written, and verbal communication skills.
• Ability to work collaboratively and deliver assigned activities within agreed timelines.

Nice-to-Have Skills and Experience

• Experience with Medidata Rave edit checks, derivations, dynamic forms, or custom functions.
• Exposure to CDISC SDTM, controlled terminology, or broader clinical data standards.
• Experience supporting external data transfers and reconciliation.
• Familiarity with laboratory, ECG, imaging, ePRO, wearable, or other non-CRF data.
• Experience with database amendments, migrations, production releases, or system upgrades.
• Knowledge of computerized system validation, traceability, change control, and issue management.
• Experience creating clinical data review reports, listings, or dashboards.
• Previous experience in a pharmaceutical, biotechnology, medical device, or CRO environment.
• Training or certification in clinical data management, EDC configuration, GCP, or system validation.