Principal Database Programmer

This is a fully remote position, open to applicants in Slovakia.

📋 Description

• Oversee all programming elements of clinical databases from the initiation of the study through to post database lock.

• Create, test, validate, implement, maintain, and provide support for clinical databases and applications.

• Direct operational study teams and programming team members on designated studies and study programs.

• Deliver operational and technical training to end users, junior personnel, and data management project team members.

• Offer planning estimates for project scope, timelines, forecasts, and resource needs.

• Maintain accountability for assigned projects and ensure timely delivery.

• Communicate project status, contract scope, and work updates to internal teams and study stakeholders.

• Estimate project hours, identify resource needs, and manage project budgets, out-of-scope work, and post-production modifications.

• Guide the design of clinical databases for clients and internal teams.

• Provide system administration and advanced technical support for applications and clinical databases.

• Diagnose and resolve software and clinical database issues.

• Create and maintain study-specific validation documents.

• Assist in data management from CRF design through database closure and archival.

• Engage in software vendor selection, EDC demonstrations, and training sessions.

• Develop and maintain SOPs and process documentation.

• Support the onboarding of new employees and organization-wide initiatives.

• Interact with sponsors, vendors, and project teams regarding project-related issues.

• Conduct software demonstrations, training sessions, and project meetings.

• Execute duties in accordance with SOPs, governmental regulations, guidelines, and industry standards.

• Perform additional duties as assigned; may include some travel.

⛳️ Requirements

• At least 8 years of relevant experience.

• Bachelor's degree and/or a combination of related work experience.

• Strong background in Oncology; experience with Autoimmune diseases is a significant advantage.

• Extensive experience with Rave and Veeva.

• Proficient in Microsoft Office Suite: Word, Excel, PowerPoint, Outlook.

• Experience in Object-Oriented Programming (C#, C++, VBS, etc.).

• Familiarity with CDISC standards (CDASH, SDTM, ADaM, etc.).

• Proficiency in multiple CDMS systems, including form building, edit checks, and complex rule development.

• Knowledge of CRF standards and contribution to the maintenance of the standards library.

• Capability to troubleshoot and assist colleagues with technical issues while building effective solutions.

• Comprehensive understanding of drug, device, and/or biologic development along with effective data management practices.

• Ability to manage a diverse range of clinical research tasks.

• Exceptional organizational and communication skills.

• Professional proficiency in the English language, both written and spoken.

• Experience in the development of clinical database management systems.

• Background in a clinical, scientific, or healthcare discipline.

• Strong leadership and interpersonal skills.

• Preferred/optional: experience across various therapeutic areas, different database programming systems, independent planning, minimal-direction work, collaboration, organization, communication, negotiation, prioritization, customer service, and client relationship management.

🏝️ Benefits

• Full-time, permanent position.

• Fully remote work available from locations in Europe.

• Potential travel may be required.