Principal Database Programmer

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

📋 Description

• Oversee all programming functions related to clinical databases and applications from the initiation of the study until post database lock.

• Direct operational study teams and programming team members for the assigned studies and study programs.

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

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

• Maintain accountability for assigned projects and ensure timely delivery.

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

• Anticipate project hours, determine resource needs, and manage project budgets, including out-of-scope work and post-production modifications.

• Offer insights and recommendations on clinical database design to clients and internal teams.

• Construct, develop, test, validate, maintain, and support clinical databases, programs, and third-party applications.

• Provide system administration and advanced technical support.

• Diagnose and resolve software and clinical database issues.

• Create and maintain study-specific validation documentation.

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

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

• Contribute to SOPs and process documentation related to data and database management.

• Aid in the onboarding of new hires and lead cross-functional and organization-wide initiatives as applicable.

• Communicate with sponsors, vendors, and project teams about project-related issues.

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

• Execute responsibilities in compliance with SOPs, government regulations, guidelines, and industry standards.

• Undertake other assigned responsibilities.

⛳️ Requirements

• At least 8 years of relevant experience.

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

• Extensive experience in Oncology; experience with Autoimmune diseases is a strong plus.

• Significant experience with Rave and Veeva.

• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.

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

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

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

• Awareness of CRF standards and contribution to maintaining the standards library.

• Capacity to troubleshoot and assist peers with technical issues and develop solutions.

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

• Capable of managing various clinical research tasks.

• Exceptional organizational and communication skills.

• Professional command of the English language, both written and spoken.

• Experience in clinical database management system development.

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

• Strong leadership and interpersonal abilities.

🏝️ Benefits

• Full-time, permanent position.

• Fully remote work available from European locations.

• May involve some travel.